Trial Outcomes & Findings for A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB) (NCT NCT04449029)

Last Updated: 2023-05-16

Results Overview

The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

457 participants

Primary outcome timeframe

Up to Week 48

Results posted on

2023-05-16

Participant Flow

A total of 457 participants were enrolled in the study. These 457 participants were from 2 different set of populations (referred here after as on nucleos(t)ide \[NA\] and not on NA therapy). Participants from these subpopulations were randomized in a ratio of 3:3:3:1 into 4 treatment arms for each population (total of 8 arms).

Participant milestones

Participant milestones
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Overall Study STARTED	68	68	68	23	70	68	68	24
Overall Study COMPLETED	65	65	66	22	64	66	63	24
Overall Study NOT COMPLETED	3	3	2	1	6	2	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
Overall Study Adverse Event	0	1	1	0	1	0	1
Overall Study Lost to Follow-up	0	1	0	0	0	0	0
Overall Study Protocol Violation	0	1	0	0	0	0	0
Overall Study Physician Decision	0	0	0	0	0	1	0
Overall Study Withdrawal by Subject	3	0	1	1	5	1	4

Baseline Characteristics

A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) n=23 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	Total n=457 Participants Total of all reporting groups
Age, Continuous	49.0 YEARS STANDARD_DEVIATION 11.54 • n=5 Participants	46.1 YEARS STANDARD_DEVIATION 12.60 • n=7 Participants	47.4 YEARS STANDARD_DEVIATION 11.18 • n=5 Participants	49.8 YEARS STANDARD_DEVIATION 11.21 • n=4 Participants	44.5 YEARS STANDARD_DEVIATION 11.10 • n=21 Participants	43.8 YEARS STANDARD_DEVIATION 9.92 • n=8 Participants	40.7 YEARS STANDARD_DEVIATION 11.10 • n=8 Participants	42.4 YEARS STANDARD_DEVIATION 12.02 • n=24 Participants	42.9 YEARS STANDARD_DEVIATION 10.90 • n=42 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	6 Participants n=4 Participants	37 Participants n=21 Participants	27 Participants n=8 Participants	29 Participants n=8 Participants	13 Participants n=24 Participants	168 Participants n=42 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	49 Participants n=7 Participants	51 Participants n=5 Participants	17 Participants n=4 Participants	33 Participants n=21 Participants	41 Participants n=8 Participants	39 Participants n=8 Participants	11 Participants n=24 Participants	289 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian	36 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	12 Participants n=4 Participants	37 Participants n=21 Participants	44 Participants n=8 Participants	38 Participants n=8 Participants	12 Participants n=24 Participants	250 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	4 Participants n=8 Participants	6 Participants n=8 Participants	1 Participants n=24 Participants	27 Participants n=42 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants	32 Participants n=7 Participants	26 Participants n=5 Participants	11 Participants n=4 Participants	24 Participants n=21 Participants	20 Participants n=8 Participants	24 Participants n=8 Participants	11 Participants n=24 Participants	178 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to Week 48

Population: The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants Achieving Sustained Virologic Response (SVR)	6 Participants	6 Participants	2 Participants	0 Participants	7 Participants	4 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.

Participants achieving HBsAg and HBV DNA levels \<LLOQ at the end of treatment (EOT) were reported.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants Achieving HBsAg and HBV DNA<LLOQ	16 Participants	9 Participants	8 Participants	4 Participants	17 Participants	10 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: At Baseline and Week 24

Population: The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis.

Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg< LLOQ, at baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg decline <0.5 log10 IU/mL	12 Participants	21 Participants	37 Participants	4 Participants	8 Participants	14 Participants	29 Participants	8 Participants
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg decline >=0.5 log10 IU/mL	52 Participants	42 Participants	20 Participants	17 Participants	55 Participants	48 Participants	22 Participants	15 Participants
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg decline >=1 log10 IU/mL	48 Participants	38 Participants	14 Participants	17 Participants	51 Participants	36 Participants	18 Participants	15 Participants
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg decline >=1.5 log10 IU/mL	42 Participants	32 Participants	12 Participants	15 Participants	48 Participants	30 Participants	9 Participants	12 Participants
Number of Participants With Categorical Changes From Baseline in HBsAg Values HBsAg decline >=3 log10 IU/mL	34 Participants	16 Participants	5 Participants	10 Participants	35 Participants	13 Participants	4 Participants	9 Participants

SECONDARY outcome

Timeframe: At Baseline and Week 24

Population: The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.

Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of \<1, \>=1, \>=2, and \>=3 log IU/mL.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants With Categorical Changes From Baseline in HBV DNA Values HBV DNA < LLOQ, at Baseline	66 Participants	66 Participants	66 Participants	22 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Categorical Changes From Baseline in HBV DNA Values HBV DNA decline <1 log10 IU/mL	2 Participants	0 Participants	0 Participants	0 Participants	3 Participants	12 Participants	21 Participants	3 Participants
Number of Participants With Categorical Changes From Baseline in HBV DNA Values HBV DNA decline >=1 log10 IU/mL	11 Participants	4 Participants	13 Participants	3 Participants	51 Participants	44 Participants	30 Participants	18 Participants
Number of Participants With Categorical Changes From Baseline in HBV DNA Values HBV DNA decline >=2 log10 IU/mL	0 Participants	0 Participants	0 Participants	0 Participants	40 Participants	23 Participants	19 Participants	14 Participants
Number of Participants With Categorical Changes From Baseline in HBV DNA Values HBV DNA decline >=3 log10 IU/mL	0 Participants	0 Participants	0 Participants	0 Participants	27 Participants	19 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: At Baseline and Week 24

The ALT normalization (ALT≤ upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN. Participants who achieved ALT normalization were reported.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants With Alanine Aminotransferase (ALT) Normalization Participants with ALT > ULN, at Baseline	6 Participants	7 Participants	6 Participants	2 Participants	20 Participants	20 Participants	21 Participants	9 Participants
Number of Participants With Alanine Aminotransferase (ALT) Normalization Participants with ALT normalization, at Week 24	3 Participants	6 Participants	5 Participants	0 Participants	10 Participants	11 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 48

Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT\>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT \>ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=6 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=7 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=6 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=2 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=20 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=20 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=21 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=9 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Median Time to ALT Normalization	16.6 Weeks Interval 1.1 to Upper limit was Not estimable (NE) due to an insufficient number of participants with events.	4.1 Weeks Interval 1.0 to 11.9	1 Weeks Interval 1.0 to 8.1	7 Weeks Interval 1.1 to Upper limit was NE due to an insufficient number of participants.	13.4 Weeks Interval 2.1 to Upper limit was NE due to an insufficient number of participants with events	15.1 Weeks Interval 4.3 to 18.1	10.7 Weeks Interval 5.1 to 21.1	18.1 Weeks Interval 1.0 to 32.1

SECONDARY outcome

Timeframe: Up to Week 48

Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)	3 Participants	4 Participants	5 Participants	2 Participants	6 Participants	4 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: At Baseline, Week 12, and 24

Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean HBsAg and HBV DNA Level HBV DNA, at Week 12	0.74 Log10 (IU/mL) Standard Deviation 0.654	0.86 Log10 (IU/mL) Standard Deviation 0.700	0.67 Log10 (IU/mL) Standard Deviation 0.785	0.61 Log10 (IU/mL) Standard Deviation 0.682	3.00 Log10 (IU/mL) Standard Deviation 2.242	2.92 Log10 (IU/mL) Standard Deviation 2.142	2.68 Log10 (IU/mL) Standard Deviation 1.996	4.96 Log10 (IU/mL) Standard Deviation 2.074
Mean HBsAg and HBV DNA Level HBsAg, at Baseline	3.29 Log10 (IU/mL) Standard Deviation 0.623	3.26 Log10 (IU/mL) Standard Deviation 0.608	3.33 Log10 (IU/mL) Standard Deviation 0.588	3.43 Log10 (IU/mL) Standard Deviation 0.435	3.72 Log10 (IU/mL) Standard Deviation 0.771	3.64 Log10 (IU/mL) Standard Deviation 0.721	3.66 Log10 (IU/mL) Standard Deviation 0.675	3.76 Log10 (IU/mL) Standard Deviation 0.789
Mean HBsAg and HBV DNA Level HBsAg, at Week 12	1.20 Log10 (IU/mL) Standard Deviation 1.878	1.04 Log10 (IU/mL) Standard Deviation 1.858	1.76 Log10 (IU/mL) Standard Deviation 1.706	3.36 Log10 (IU/mL) Standard Deviation 0.431	1.39 Log10 (IU/mL) Standard Deviation 1.965	1.27 Log10 (IU/mL) Standard Deviation 2.000	1.57 Log10 (IU/mL) Standard Deviation 1.808	3.68 Log10 (IU/mL) Standard Deviation 0.798
Mean HBsAg and HBV DNA Level HBsAg, at Week 24	0.65 Log10 (IU/mL) Standard Deviation 1.939	1.45 Log10 (IU/mL) Standard Deviation 1.809	2.51 Log10 (IU/mL) Standard Deviation 1.536	0.83 Log10 (IU/mL) Standard Deviation 1.801	0.77 Log10 (IU/mL) Standard Deviation 2.016	1.88 Log10 (IU/mL) Standard Deviation 1.915	2.88 Log10 (IU/mL) Standard Deviation 1.511	1.64 Log10 (IU/mL) Standard Deviation 2.171
Mean HBsAg and HBV DNA Level HBV DNA, at Baseline	0.48 Log10 (IU/mL) Standard Deviation 0.638	0.39 Log10 (IU/mL) Standard Deviation 0.603	0.53 Log10 (IU/mL) Standard Deviation 0.659	0.40 Log10 (IU/mL) Standard Deviation 0.622	5.02 Log10 (IU/mL) Standard Deviation 1.527	5.14 Log10 (IU/mL) Standard Deviation 1.557	4.67 Log10 (IU/mL) Standard Deviation 1.497	5.57 Log10 (IU/mL) Standard Deviation 1.654
Mean HBsAg and HBV DNA Level HBV DNA, at Week 24	0.55 Log10 (IU/mL) Standard Deviation 0.654	0.56 Log10 (IU/mL) Standard Deviation 0.649	0.56 Log10 (IU/mL) Standard Deviation 0.714	0.79 Log10 (IU/mL) Standard Deviation 0.667	2.37 Log10 (IU/mL) Standard Deviation 2.137	2.93 Log10 (IU/mL) Standard Deviation 2.317	3.07 Log10 (IU/mL) Standard Deviation 1.938	3.04 Log10 (IU/mL) Standard Deviation 2.224

SECONDARY outcome

Timeframe: At Baseline, Week 12, and 24

Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=18 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=20 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=24 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=7 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=21 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=7 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level HBeAg, at Week 12	0.06 Log10 unit per milliliter (U/mL) Standard Deviation 1.027	-0.21 Log10 unit per milliliter (U/mL) Standard Deviation 0.732	0.19 Log10 unit per milliliter (U/mL) Standard Deviation 1.089	0.60 Log10 unit per milliliter (U/mL) Standard Deviation 1.310	1.84 Log10 unit per milliliter (U/mL) Standard Deviation 1.805	1.52 Log10 unit per milliliter (U/mL) Standard Deviation 1.831	1.07 Log10 unit per milliliter (U/mL) Standard Deviation 1.551	2.79 Log10 unit per milliliter (U/mL) Standard Deviation 0.725
Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level HBeAg, at Week 24	-0.41 Log10 unit per milliliter (U/mL) Standard Deviation 0.635	-0.48 Log10 unit per milliliter (U/mL) Standard Deviation 0.752	-0.19 Log10 unit per milliliter (U/mL) Standard Deviation 1.071	0.08 Log10 unit per milliliter (U/mL) Standard Deviation 1.497	1.18 Log10 unit per milliliter (U/mL) Standard Deviation 2.064	1.34 Log10 unit per milliliter (U/mL) Standard Deviation 1.936	0.89 Log10 unit per milliliter (U/mL) Standard Deviation 1.667	1.06 Log10 unit per milliliter (U/mL) Standard Deviation 2.165
Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level HBeAg, at Baseline	0.49 Log10 unit per milliliter (U/mL) Standard Deviation 1.014	0.12 Log10 unit per milliliter (U/mL) Standard Deviation 0.756	0.36 Log10 unit per milliliter (U/mL) Standard Deviation 1.053	0.63 Log10 unit per milliliter (U/mL) Standard Deviation 1.323	2.13 Log10 unit per milliliter (U/mL) Standard Deviation 1.564	2.52 Log10 unit per milliliter (U/mL) Standard Deviation 0.919	1.77 Log10 unit per milliliter (U/mL) Standard Deviation 1.612	2.84 Log10 unit per milliliter (U/mL) Standard Deviation 0.743

SECONDARY outcome

Timeframe: At Baseline, Week 12, and 24

Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Change From Baseline in HBsAg and HBV DNA Level HBsAg, at Baseline	3.29 log IU/mL Standard Deviation 0.623	3.26 log IU/mL Standard Deviation 0.608	3.33 log IU/mL Standard Deviation 0.588	3.43 log IU/mL Standard Deviation 0.435	3.72 log IU/mL Standard Deviation 0.771	3.64 log IU/mL Standard Deviation 0.721	3.66 log IU/mL Standard Deviation 0.675	3.76 log IU/mL Standard Deviation 0.789
Mean Change From Baseline in HBsAg and HBV DNA Level HBsAg, at Week 12	-2.09 log IU/mL Standard Deviation 1.649	-2.23 log IU/mL Standard Deviation 1.597	-1.59 log IU/mL Standard Deviation 1.474	-0.03 log IU/mL Standard Deviation 0.089	-2.37 log IU/mL Standard Deviation 1.585	-2.41 log IU/mL Standard Deviation 1.562	-2.06 log IU/mL Standard Deviation 1.638	-0.08 log IU/mL Standard Deviation 0.292
Mean Change From Baseline in HBsAg and HBV DNA Level HBsAg, at Week 24	-2.62 log IU/mL Standard Deviation 1.653	-1.81 log IU/mL Standard Deviation 1.488	-0.83 log IU/mL Standard Deviation 1.248	-2.57 log IU/mL Standard Deviation 1.671	-2.96 log IU/mL Standard Deviation 1.656	-1.77 log IU/mL Standard Deviation 1.489	-0.77 log IU/mL Standard Deviation 1.108	-2.09 log IU/mL Standard Deviation 1.764
Mean Change From Baseline in HBsAg and HBV DNA Level HBV DNA, at Baseline	3.29 log IU/mL Standard Deviation 0.623	3.26 log IU/mL Standard Deviation 0.608	3.33 log IU/mL Standard Deviation 0.588	3.43 log IU/mL Standard Deviation 0.435	3.72 log IU/mL Standard Deviation 0.771	3.64 log IU/mL Standard Deviation 0.721	3.66 log IU/mL Standard Deviation 0.675	3.76 log IU/mL Standard Deviation 0.789
Mean Change From Baseline in HBsAg and HBV DNA Level HBV DNA, at Week 12	0.24 log IU/mL Standard Deviation 0.793	0.47 log IU/mL Standard Deviation 0.773	0.16 log IU/mL Standard Deviation 0.942	0.19 log IU/mL Standard Deviation 0.727	-1.96 log IU/mL Standard Deviation 1.365	-2.22 log IU/mL Standard Deviation 1.592	-1.92 log IU/mL Standard Deviation 1.349	-0.54 log IU/mL Standard Deviation 1.421
Mean Change From Baseline in HBsAg and HBV DNA Level HBV DNA, at Week 24	0.06 log IU/mL Standard Deviation 0.831	0.17 log IU/mL Standard Deviation 0.661	0.09 log IU/mL Standard Deviation 0.928	0.33 log IU/mL Standard Deviation 0.928	-2.66 log IU/mL Standard Deviation 1.646	-2.2 log IU/mL Standard Deviation 1.68	-1.52 log IU/mL Standard Deviation 1.637	-2.6 log IU/mL Standard Deviation 2.001

SECONDARY outcome

Timeframe: At Baseline, Week 12, and 24

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=18 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=20 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=24 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=7 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=21 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=7 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Change From Baseline in HBeAg Level HBeAg, at Baseline	0.49 Log u/mL Standard Deviation 1.014	0.12 Log u/mL Standard Deviation 0.756	0.36 Log u/mL Standard Deviation 1.053	0.63 Log u/mL Standard Deviation 1.323	2.13 Log u/mL Standard Deviation 1.564	2.52 Log u/mL Standard Deviation 0.919	1.77 Log u/mL Standard Deviation 1.612	2.84 Log u/mL Standard Deviation 0.743
Mean Change From Baseline in HBeAg Level HBeAg, at Week 12	-0.52 Log u/mL Standard Deviation 0.874	-0.42 Log u/mL Standard Deviation 0.480	-0.33 Log u/mL Standard Deviation 0.343	-0.17 Log u/mL Standard Deviation 0.453	-0.65 Log u/mL Standard Deviation 0.919	-1.25 Log u/mL Standard Deviation 1.522	-0.94 Log u/mL Standard Deviation 1.618	-0.14 Log u/mL Standard Deviation 0.313
Mean Change From Baseline in HBeAg Level HBeAg, at WeeK 24	-0.85 Log u/mL Standard Deviation 1.071	-0.56 Log u/mL Standard Deviation 0.811	-0.46 Log u/mL Standard Deviation 0.595	-0.56 Log u/mL Standard Deviation 0.598	-1.01 Log u/mL Standard Deviation 1.426	-1.18 Log u/mL Standard Deviation 1.532	-0.70 Log u/mL Standard Deviation 1.673	-1.78 Log u/mL Standard Deviation 2.057

SECONDARY outcome

Timeframe: At Baseline, Week 36, and 48

Population: The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.

Blood samples were collected to assess anti-HBsAg level at indicated timepoints.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level At baseline	0.67 Log10 IU/mL Standard Deviation 0.289	0.65 Log10 IU/mL Standard Deviation 0.165	0.64 Log10 IU/mL Standard Deviation 0.129	0.66 Log10 IU/mL Standard Deviation 0.287	0.65 Log10 IU/mL Standard Deviation 0.284	0.69 Log10 IU/mL Standard Deviation 0.303	0.62 Log10 IU/mL Standard Deviation 0.150	0.74 Log10 IU/mL Standard Deviation 0.307
Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level At Week 36	0.94 Log10 IU/mL Standard Deviation 0.534	0.83 Log10 IU/mL Standard Deviation 0.401	0.74 Log10 IU/mL Standard Deviation 0.333	0.79 Log10 IU/mL Standard Deviation 0.368	1.01 Log10 IU/mL Standard Deviation 0.660	0.82 Log10 IU/mL Standard Deviation 0.385	0.74 Log10 IU/mL Standard Deviation 0.347	0.90 Log10 IU/mL Standard Deviation 0.437
Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level At Week 48	0.88 Log10 IU/mL Standard Deviation 0.471	0.77 Log10 IU/mL Standard Deviation 0.368	0.70 Log10 IU/mL Standard Deviation 0.277	0.75 Log10 IU/mL Standard Deviation 0.326	0.91 Log10 IU/mL Standard Deviation 0.567	0.79 Log10 IU/mL Standard Deviation 0.369	0.71 Log10 IU/mL Standard Deviation 0.296	0.83 Log10 IU/mL Standard Deviation 0.356

SECONDARY outcome

Timeframe: At Baseline, Week 12, and 24

Population: The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.

Blood samples were collected to assess anti-HBsAg level at indicated timepoints.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=23 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 Participants All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Change From Baseline in Anti-HBsAg Level At Baseline	0.67 Log10 IU/mL Standard Deviation 0.289	0.65 Log10 IU/mL Standard Deviation 0.165	0.64 Log10 IU/mL Standard Deviation 0.129	0.66 Log10 IU/mL Standard Deviation 0.287	0.65 Log10 IU/mL Standard Deviation 0.284	0.69 Log10 IU/mL Standard Deviation 0.303	0.62 Log10 IU/mL Standard Deviation 0.150	0.74 Log10 IU/mL Standard Deviation 0.307
Mean Change From Baseline in Anti-HBsAg Level At Week 12	0.28 Log10 IU/mL Standard Deviation 0.481	0.18 Log10 IU/mL Standard Deviation 0.343	0.11 Log10 IU/mL Standard Deviation 0.319	0.13 Log10 IU/mL Standard Deviation 0.250	0.37 Log10 IU/mL Standard Deviation 0.615	0.13 Log10 IU/mL Standard Deviation 0.353	0.12 Log10 IU/mL Standard Deviation 0.221	0.16 Log10 IU/mL Standard Deviation 0.355
Mean Change From Baseline in Anti-HBsAg Level At Week 24	0.22 Log10 IU/mL Standard Deviation 0.429	0.12 Log10 IU/mL Standard Deviation 0.335	0.07 Log10 IU/mL Standard Deviation 0.267	0.09 Log10 IU/mL Standard Deviation 0.239	0.26 Log10 IU/mL Standard Deviation 0.507	0.10 Log10 IU/mL Standard Deviation 0.319	0.09 Log10 IU/mL Standard Deviation 0.203	0.09 Log10 IU/mL Standard Deviation 0.203

SECONDARY outcome

Timeframe: Up to Week 24

Population: The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).

Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=12 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=12 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836	55.214 hourmicrograms per milliliter (hug/mL) Standard Deviation 22.9901	140.312 hourmicrograms per milliliter (hug/mL) Standard Deviation 37.3548	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=12 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=12 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Maximum Observed Concentration (Cmax) of GSK3228836	6.112 ug/mL Standard Deviation 2.8112	14.956 ug/mL Standard Deviation 5.6592	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=12 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=12 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Median Time of Maximum Observed Concentration (Tmax) of GSK3228836	3.008 hour Interval 2.0 to 4.02	3.017 hour Interval 2.0 to 5.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=7 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=5 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean AUC0-24h of NA Therapies	2753.908 hnanograms per milliliter (hng/mL) Standard Deviation 661.3392	308.167 hnanograms per milliliter (hng/mL) Standard Deviation 104.8297	24.43 hnanograms per milliliter (hng/mL) Standard Deviation 6.761	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=7 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=5 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Ctau of NA Therapies	57.04 ng/mL Standard Deviation 17.0787	10.31 ng/mL Standard Deviation 3.4802	0.478 ng/mL Standard Deviation 0.1055	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=7 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=5 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Cmax of NA Therapies	318.857 ng/mL Standard Deviation 95.94	19.36 ng/mL Standard Deviation 5.85	6.526 ng/mL Standard Deviation 2.27	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=7 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=5 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=16 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Median Tmax of NA Therapies	1 hour Interval 0.52 to 1.47	1.417 hour Interval 0.93 to 1.55	0.983 hour Interval 0.48 to 2.02	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 48

Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=67 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=67 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Median Terminal Half-life (t1/2) of GSK3228836	28.897 Day Interval 7.52 to 191.98	24.918 Day Interval 8.84 to 216.43	27.846 Day Interval 10.19 to 149.74	38.205 Day Interval 6.87 to 161.83	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.

Outcome measures

Outcome measures
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 Participants All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=67 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 Participants All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=67 Participants All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Mean Ctau of GSK3228836 At Week 8	21.009 ng/mL Standard Deviation 9.6214	47.039 ng/mL Standard Deviation 198.1345	21.663 ng/mL Standard Deviation 14.4479	23.46 ng/mL Standard Deviation 16.6498	—	—	—	—
Mean Ctau of GSK3228836 At Week 12	23.162 ng/mL Standard Deviation 11.8963	23.234 ng/mL Standard Deviation 11.6993	21.777 ng/mL Standard Deviation 9.9248	22.789 ng/mL Standard Deviation 11.7361	—	—	—	—
Mean Ctau of GSK3228836 At Week 24	31.102 ng/mL Standard Deviation 28.7535	18.95 ng/mL Standard Deviation 14.6513	28.158 ng/mL Standard Deviation 17.0606	20.138 ng/mL Standard Deviation 19.023	—	—	—	—

Adverse Events

GSK3228836 for 24 Weeks (WK) (on NA Therapy)

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

GSK3228836 for 12+12 WK (on NA Therapy)

Serious events: 1 serious events

Other events: 59 other events

Deaths: 0 deaths

GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)

Serious events: 4 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

GSK3228836 for 24 WK (Not on NA Therapy)

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

GSK3228836 for 12+12 WK (Not on NA Therapy)

Serious events: 2 serious events

Other events: 60 other events

Deaths: 0 deaths

GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)

Serious events: 3 serious events

Other events: 61 other events

Deaths: 0 deaths

Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 participants at risk All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=67 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) n=68 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) n=23 participants at risk All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=67 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 participants at risk All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Haemorrhoids	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Chest pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Systemic inflammatory response syndrome	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations COVID-19 pneumonia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Hepatitis B	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Concussion	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Muscle injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Cerebral infarction	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Cryoglobulinaemia	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Hypotension	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).

Other adverse events

Other adverse events
Measure	GSK3228836 for 24 Weeks (WK) (on NA Therapy) n=68 participants at risk All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (on NA Therapy) n=67 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) n=68 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) n=23 participants at risk All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.	GSK3228836 for 24 WK (Not on NA Therapy) n=70 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).	GSK3228836 for 12+12 WK (Not on NA Therapy) n=67 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.	GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) n=68 participants at risk All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.	Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) n=24 participants at risk All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Urine abnormality	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Adenomyosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Amenorrhoea	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Breast pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Cervical polyp	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Cervix haemorrhage uterine	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Abnormal clotting factor	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Anaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Eosinophilia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Iron deficiency anaemia	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Leukopenia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Lymph node pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Lymphadenopathy	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Monocytosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Neutropenia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Polycythaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Splenomegaly	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Thrombocytopenia	5.9% 4/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.1% 5/70 • Number of events 9 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Cardiac disorders Angina pectoris	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Cardiac disorders Atrial fibrillation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Cardiac disorders Palpitations	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Cardiac disorders Supraventricular extrasystoles	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Cardiac disorders Tachycardia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Congenital, familial and genetic disorders Dyschromatosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Deafness	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Deafness neurosensory	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Ear pain	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Meniere's disease	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Vertigo	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Ear and labyrinth disorders Vertigo positional	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Endocrine disorders Hyperthyroidism	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Endocrine disorders Hypothyroidism	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Asthenopia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Blepharitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Dry eye	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Eye pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Keratitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Noninfective conjunctivitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Ocular hyperaemia	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Eye disorders Periorbital swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal discomfort	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal distension	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal pain	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal pain lower	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Abdominal tenderness	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Angular cheilitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Change of bowel habit	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Constipation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Dental caries	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Diarrhoea	8.8% 6/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Dry mouth	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Dyspepsia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Faecaloma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Faeces discoloured	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Flatulence	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Food poisoning	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gastritis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gingival bleeding	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gingival pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Gingival ulceration	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Haematochezia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Haemorrhoids	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Irritable bowel syndrome	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Large intestine polyp	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Mouth ulceration	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Nausea	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.0% 7/70 • Number of events 9 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Oesophageal spasm	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Stomatitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Tooth disorder	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Toothache	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Gastrointestinal disorders Vomiting	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Asthenia	7.4% 5/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.3% 7/68 • Number of events 11 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Chest discomfort	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Chest pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Chills	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.1% 5/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Energy increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Fatigue	7.4% 5/68 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.3% 7/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	18.6% 13/70 • Number of events 19 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.4% 7/67 • Number of events 15 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.8% 8/68 • Number of events 11 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Feeling abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Hyperthermia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Influenza like illness	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site anaesthesia	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site bruising	10.3% 7/68 • Number of events 36 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.4% 11/67 • Number of events 17 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.3% 7/68 • Number of events 23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	17.4% 4/23 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	18.6% 13/70 • Number of events 42 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	14.9% 10/67 • Number of events 29 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.6% 14/68 • Number of events 33 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.7% 4/24 • Number of events 10 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site discolouration	11.8% 8/68 • Number of events 22 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.4% 9/67 • Number of events 65 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.6% 14/68 • Number of events 92 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.7% 2/23 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	18.6% 13/70 • Number of events 39 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.4% 11/67 • Number of events 46 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.8% 6/68 • Number of events 37 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site discomfort	2.9% 2/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.4% 9/67 • Number of events 62 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.2% 9/68 • Number of events 54 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	9.0% 6/67 • Number of events 25 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 25 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site erosion	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site erythema	52.9% 36/68 • Number of events 216 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	55.2% 37/67 • Number of events 175 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	50.0% 34/68 • Number of events 194 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	21.7% 5/23 • Number of events 22 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	48.6% 34/70 • Number of events 264 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	44.8% 30/67 • Number of events 150 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	54.4% 37/68 • Number of events 179 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	41.7% 10/24 • Number of events 23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site haematoma	7.4% 5/68 • Number of events 9 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 15 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.4% 8/70 • Number of events 17 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 12 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site haemorrhage	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site hypoaesthesia	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site induration	4.4% 3/68 • Number of events 14 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.6% 6/70 • Number of events 20 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.4% 7/67 • Number of events 16 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site nodule	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site pain	16.2% 11/68 • Number of events 45 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	22.4% 15/67 • Number of events 59 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	30.9% 21/68 • Number of events 118 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	26.1% 6/23 • Number of events 16 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	28.6% 20/70 • Number of events 198 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	19.4% 13/67 • Number of events 61 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.6% 14/68 • Number of events 66 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	25.0% 6/24 • Number of events 41 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site pruritus	20.6% 14/68 • Number of events 88 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	25.4% 17/67 • Number of events 78 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	22.1% 15/68 • Number of events 100 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.7% 2/23 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	32.9% 23/70 • Number of events 198 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	23.9% 16/67 • Number of events 85 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	27.9% 19/68 • Number of events 98 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site swelling	5.9% 4/68 • Number of events 45 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 12 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	19.1% 13/68 • Number of events 70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	14.3% 10/70 • Number of events 69 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.4% 7/67 • Number of events 44 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.4% 5/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Injection site warmth	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.5% 5/67 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 39 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 34 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 19 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Malaise	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.7% 2/23 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Nodule	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Non-cardiac chest pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Oedema peripheral	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Pain	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Peripheral swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Pyrexia	14.7% 10/68 • Number of events 14 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	9.0% 6/67 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	14.7% 10/68 • Number of events 19 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	26.1% 6/23 • Number of events 7 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	21.4% 15/70 • Number of events 23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	25.4% 17/67 • Number of events 38 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	25.0% 17/68 • Number of events 23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.7% 4/24 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Scar inflammation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Sensation of foreign body	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
General disorders Vaccination site pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Gallbladder polyp	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hepatitis acute	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Immune system disorders Food allergy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Immune system disorders Immunodeficiency	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Immune system disorders Seasonal allergy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Immune system disorders Type III immune complex mediated reaction	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Asymptomatic bacteriuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Bacterial infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Bacteriuria	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Bronchitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations COVID-19	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.9% 8/67 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.4% 5/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	9.0% 6/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Cellulitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Chronic hepatitis B	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Conjunctivitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Cystitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Diarrhoea infectious	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Epididymitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Folliculitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Fungal infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Fungal skin infection	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Furuncle	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Gastroenteritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Genital herpes	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Gingivitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Helicobacter gastritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Hepatitis B	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Herpes dermatitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Herpes simplex	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Herpes virus infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Herpes zoster	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Hordeolum	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Influenza	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Injection site abscess	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Injection site cellulitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Nasopharyngitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.4% 5/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	17.4% 4/23 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Oral herpes	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Oral infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Otitis externa	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Otitis media	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Otitis media acute	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Parotitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Periodontitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Pharyngitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Pustule	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Respiratory tract infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Respiratory tract infection viral	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Sinusitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Skin infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Subcutaneous abscess	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Suspected COVID-19	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Tonsillitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Tooth abscess	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Tooth infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Upper respiratory tract infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Urethritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Urinary tract infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Vaginal infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Vaginitis gardnerella	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Viral infection	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Viral upper respiratory tract infection	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Infections and infestations Vulvovaginal candidiasis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Animal bite	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Arthropod bite	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Back injury	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Contusion	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Eye injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Fall	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Hand fracture	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Nail injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Skin injury	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Sunburn	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Tooth avulsion	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Tooth dislocation	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Tooth fracture	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Tooth injury	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Injury, poisoning and procedural complications Vaccination complication	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Activated partial thromboplastin time prolonged	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Alanine aminotransferase increased	10.3% 7/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.9% 8/67 • Number of events 10 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	21.7% 5/23 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	24.3% 17/70 • Number of events 25 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	22.4% 15/67 • Number of events 18 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	17.6% 12/68 • Number of events 21 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.7% 4/24 • Number of events 9 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Albumin urine present	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Antineutrophil cytoplasmic antibody positive	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Antinuclear antibody positive	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Aspartate aminotransferase increased	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.0% 3/23 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.4% 8/70 • Number of events 11 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.4% 9/67 • Number of events 12 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.3% 7/68 • Number of events 9 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Autoantibody positive	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Bilirubin conjugated increased	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood alkaline phosphatase increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood bilirubin increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood calcium decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood creatine increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood creatinine increased	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood potassium increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Blood pressure increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Body temperature increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 7 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations C-reactive protein increased	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Complement factor C3 decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.0% 7/70 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.8% 6/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.7% 4/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Complement factor C4 decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.1% 5/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	12.5% 3/24 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Complement factor abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Complement factor increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.6% 6/70 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Creatinine renal clearance decreased	2.9% 2/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	9.0% 6/67 • Number of events 21 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 10 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Creatinine urine increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Crystal urine present	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Eosinophil count increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Gamma-glutamyltransferase increased	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Glomerular filtration rate decreased	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Hepatic enzyme increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Hepatitis B DNA assay positive	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Immature granulocyte count increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations International normalised ratio increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Liver function test abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Mean cell volume decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Neutrophil count decreased	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Platelet count decreased	5.9% 4/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.4% 8/70 • Number of events 11 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Protein urine present	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Prothrombin time prolonged	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Red blood cells urine positive	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Total complement activity decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Transaminases increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Urinary sediment present	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Urine albumin/creatinine ratio	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Urine albumin/creatinine ratio increased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Urine analysis abnormal	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations Urine leukocyte esterase positive	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Investigations White blood cell count decreased	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Cell death	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Decreased appetite	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 15 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Diabetes mellitus	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Iron deficiency	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Polydipsia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Vitamin B complex deficiency	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 3/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.8% 6/68 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Back pain	5.9% 4/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.5% 5/67 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.8% 6/68 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	8.3% 2/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Muscle spasms	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Myalgia	7.4% 5/68 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.9% 4/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	14.3% 10/70 • Number of events 12 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.4% 7/67 • Number of events 10 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	12.5% 3/24 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Neck pain	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Osteoporosis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	5.7% 4/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Musculoskeletal and connective tissue disorders Tendonitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Ageusia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Dizziness	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Dysgeusia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Headache	7.4% 5/68 • Number of events 10 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	9.0% 6/67 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	11.8% 8/68 • Number of events 15 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	13.0% 3/23 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.0% 14/70 • Number of events 25 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.9% 14/67 • Number of events 50 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	20.6% 14/68 • Number of events 26 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	16.7% 4/24 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Hypoaesthesia	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Lethargy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Migraine	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Paraesthesia	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Sciatica	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Somnolence	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Nervous system disorders Syncope	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Anxiety	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Depressed mood	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Depression	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Insomnia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Irritability	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Sleep disorder	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Psychiatric disorders Stress	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Albuminuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Cylindruria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Dysuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Glycosuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Haematuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Ketonuria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Leukocyturia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Nephrocalcinosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Nephrolithiasis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Nephropathy toxic	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Proteinuria	1.5% 1/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Renal and urinary disorders Renal cyst	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Dysmenorrhoea	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Menstrual disorder	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Menstruation irregular	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Pelvic pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Vaginal discharge	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 3/70 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Acne	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Asteatosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Blood blister	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Dry skin	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Eczema	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Erythema	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Hand dermatitis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Hyperhidrosis	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Nail bed bleeding	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Papule	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Pruritus	4.4% 3/68 • Number of events 6 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	3.0% 2/67 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.1% 5/70 • Number of events 5 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	6.0% 4/67 • Number of events 12 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 7 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Purpura	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Rash	5.9% 4/68 • Number of events 8 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 7 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	10.4% 7/67 • Number of events 11 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	7.4% 5/68 • Number of events 13 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.2% 1/24 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Skin discolouration	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.4% 3/68 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 3 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Umbilical erythema	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.3% 1/23 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	4.5% 3/67 • Number of events 4 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Skin and subcutaneous tissue disorders Urticarial vasculitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/70 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Haematoma	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Hot flush	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Hypertension	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/68 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	2.9% 2/70 • Number of events 2 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.5% 1/67 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Hypotension	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Varicose vein	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Vascular pain	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
Vascular disorders Vasculitis	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/23 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	1.4% 1/70 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/67 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/68 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).	0.00% 0/24 • All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks. The safety population included participants who received at least one dose of study treatment. The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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