Trial Outcomes & Findings for A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (NCT NCT03982186)

Last Updated: 2025-02-04

Results Overview

Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

471 participants

Primary outcome timeframe

Week 48

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Overall Study STARTED	95	96	93	94	48	45
Overall Study Double Blind Phase	95	96	93	93	48	45
Overall Study Follow up Phase 1:	81	70	71	85	47	44
Overall Study Follow up Phase 2:	8	17	15	5	0	1
Overall Study Follow up Phase 3:	3	8	5	0	0	0
Overall Study Extended Follow up	3	7	5	0	0	0
Overall Study Treated	95	96	93	94	48	45
Overall Study COMPLETED	92	90	90	85	45	45
Overall Study NOT COMPLETED	3	6	3	9	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Overall Study Lost to Follow-up	0	1	2	1	1
Overall Study Physician Decision	0	1	0	0	0
Overall Study Withdrawal by Subject	3	4	1	7	2
Overall Study Randomized and not treated	0	0	0	1	0

Baseline Characteristics

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Participants Received n=95 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=96 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Total n=470 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 10.72 • n=5 Participants	42.9 years STANDARD_DEVIATION 10.9 • n=7 Participants	43 years STANDARD_DEVIATION 11.3 • n=5 Participants	42.2 years STANDARD_DEVIATION 10.92 • n=4 Participants	43.9 years STANDARD_DEVIATION 9.8 • n=21 Participants	43.8 years STANDARD_DEVIATION 9.99 • n=8 Participants	43.0 years STANDARD_DEVIATION 10.71 • n=8 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Adults (18-64 years)	94 Participants n=5 Participants	95 Participants n=7 Participants	89 Participants n=5 Participants	93 Participants n=4 Participants	46 Participants n=21 Participants	45 Participants n=8 Participants	462 Participants n=8 Participants
Age, Customized From 65 to 84 years	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	35 Participants n=7 Participants	38 Participants n=5 Participants	32 Participants n=4 Participants	11 Participants n=21 Participants	20 Participants n=8 Participants	160 Participants n=8 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	61 Participants n=7 Participants	55 Participants n=5 Participants	61 Participants n=4 Participants	37 Participants n=21 Participants	25 Participants n=8 Participants	310 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Asian	35 Participants n=5 Participants	39 Participants n=7 Participants	39 Participants n=5 Participants	42 Participants n=4 Participants	20 Participants n=21 Participants	15 Participants n=8 Participants	190 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized White	54 Participants n=5 Participants	50 Participants n=7 Participants	48 Participants n=5 Participants	39 Participants n=4 Participants	25 Participants n=21 Participants	28 Participants n=8 Participants	244 Participants n=8 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment BELGIUM	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	19 Participants n=8 Participants
Region of Enrollment BRAZIL	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Region of Enrollment CANADA	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	20 Participants n=8 Participants
Region of Enrollment CHINA	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Region of Enrollment CZECH REPUBLIC	9 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	27 Participants n=8 Participants
Region of Enrollment FRANCE	4 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	22 Participants n=8 Participants
Region of Enrollment GERMANY	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	16 Participants n=8 Participants
Region of Enrollment ITALY	6 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	30 Participants n=8 Participants
Region of Enrollment JAPAN	10 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	18 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	61 Participants n=8 Participants
Region of Enrollment MALAYSIA	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	18 Participants n=8 Participants
Region of Enrollment POLAND	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	37 Participants n=8 Participants
Region of Enrollment RUSSIAN FEDERATION	12 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	5 Participants n=8 Participants	62 Participants n=8 Participants
Region of Enrollment SOUTH KOREA	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	10 Participants n=8 Participants
Region of Enrollment SPAIN	5 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	22 Participants n=8 Participants
Region of Enrollment THAILAND	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	23 Participants n=8 Participants
Region of Enrollment TURKEY	11 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	49 Participants n=8 Participants
Region of Enrollment UNITED KINGDOM	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	12 Participants n=8 Participants
Region of Enrollment UNITED STATES	1 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	21 Participants n=8 Participants
Region of Enrollment Hong Kong, S.A.R., China	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Modified Intent-to-Treat (mITT) set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48	9.4 Percentage of participants 90% Confidence Interval 4.36 • Interval 4.36 to 14.36	19.1 Percentage of participants 90% Confidence Interval 12.76 • Interval 12.76 to 27.06	16.3 Percentage of participants 90% Confidence Interval 10.33 • Interval 10.33 to 23.99	5.5 Percentage of participants 90% Confidence Interval 2.19 • Interval 2.19 to 11.21	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.05	2.2 Percentage of participants 90% Confidence Interval 0.11 • Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.

An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=95 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=96 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	71.6 Percentage of participants	64.6 Percentage of participants	71.0 Percentage of participants	74.2 Percentage of participants	85.4 Percentage of participants	66.7 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=81 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=70 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=71 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=85 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=47 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=44 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 1: Percentage of Participants With TEAEs	48.1 Percentage of participants	45.7 Percentage of participants	56.3 Percentage of participants	44.7 Percentage of participants	55.3 Percentage of participants	31.8 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=8 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=17 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=15 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=1 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 2: Percentage of Participants With TEAEs	37.5 Percentage of participants	29.4 Percentage of participants	60.0 Percentage of participants	60.0 Percentage of participants	—	0 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=3 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=8 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 3: Percentage of Participants With TEAEs	33.3 Percentage of participants	37.5 Percentage of participants	20.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Extended Follow up Week 1 to extended follow up Week 48

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=3 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=7 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Extended Follow-up Phase: Percentage of Participants With TEAEs	66.7 Percentage of participants	71.4 Percentage of participants	100.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=95 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=96 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs)	2.1 Percentage of participants	3.1 Percentage of participants	2.2 Percentage of participants	1.1 Percentage of participants	4.2 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=81 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=70 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=71 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=85 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=47 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=44 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 1: Percentage of Participants With SAEs	1.2 Percentage of participants	7.1 Percentage of participants	4.2 Percentage of participants	1.2 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=8 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=17 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=15 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=1 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 2: Percentage of Participants With SAEs	12.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	0 Percentage of participants

SECONDARY outcome

Timeframe: From Week 48 up to Week 96

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=3 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=8 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Follow-up Phase 3: Percentage of Participants With SAEs	33.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Extended Follow up Week 1 to extended follow up Week 48

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=3 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=7 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Extended Follow-up Phase: Percentage of Participants With SAEs	0 Percentage of participants	14.3 Percentage of participants	40.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories. Here 'n=0' signifies no participants were available for analysis at specified timepoints.

Percentage of participants with abnormalities in clinical laboratory tests (hematology: Abnormally low \[AL\] and Abnormally high \[AH\] basophils, eosinophils, erthrocytes mean corpuscular hemoglobin concentration, erthrocytes mean corpuscular heamoglobin, erthrocytes mean corpuscular volume, erthrocytes, hematocrit, lymphocytes atypical, metamyelocytes, monocytes, myelocytes, neutrophils, segmented, reticulocytes) were reported. Abnormality was determined at the investigator's discretion. Here, M.C: Mean corpuscular. Participants with abnormally low or high values were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=93 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Basophils AH	1.1 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Basophils AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Basophils AH	2.2 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Eosinophils AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Eosinophils AH	3.2 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	3.3 Percentage of participants	14.6 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Eosinophils AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Eosinophils AH	1.1 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C HGB Conc. AL	10.8 Percentage of participants	13.8 Percentage of participants	26.9 Percentage of participants	14.1 Percentage of participants	16.7 Percentage of participants	22.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Ery. M.C HGB Conc. AL	13.0 Percentage of participants	17.4 Percentage of participants	24.4 Percentage of participants	18.4 Percentage of participants	13.0 Percentage of participants	22.7 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C Hemoglobin AL	3.2 Percentage of participants	4.3 Percentage of participants	7.5 Percentage of participants	6.5 Percentage of participants	6.3 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U::Ery. M.C Hemoglobin AH	4.3 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C Volume AH	29.0 Percentage of participants	19.1 Percentage of participants	15.1 Percentage of participants	16.3 Percentage of participants	29.2 Percentage of participants	13.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Ery. M.C Volume AH	16.3 Percentage of participants	12.0 Percentage of participants	13.3 Percentage of participants	13.8 Percentage of participants	19.6 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Erythrocytes AL	20.4 Percentage of participants	14.9 Percentage of participants	24.7 Percentage of participants	15.2 Percentage of participants	27.1 Percentage of participants	22.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Erythrocytes AH	0 Percentage of participants	0 Percentage of participants	3.2 Percentage of participants	3.3 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Erythrocytes AL	18.3 Percentage of participants	13.0 Percentage of participants	21.1 Percentage of participants	19.5 Percentage of participants	21.7 Percentage of participants	13.6 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Erythrocytes AH	0 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	3.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Hematocrit AL	6.5 Percentage of participants	13.0 Percentage of participants	10.0 Percentage of participants	11.5 Percentage of participants	13.0 Percentage of participants	11.4 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Lymphocytes Atypical AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Lymphocytes Atypical AH	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	—	100.0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Lymphocyte Atypical/Leukocyte AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Lymphocyte Atypical/Leukocyte AH	80.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:LymphocyteAtypical/Leukocyte AH	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	—	100.0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Monocytes AL	10.8 Percentage of participants	12.8 Percentage of participants	5.4 Percentage of participants	5.4 Percentage of participants	4.2 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Monocytes AH	1.1 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	6.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Monocytes AL	4.3 Percentage of participants	7.6 Percentage of participants	7.8 Percentage of participants	1.1 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Neutrophils, Segmented AL	36.6 Percentage of participants	24.5 Percentage of participants	23.7 Percentage of participants	25.0 Percentage of participants	35.4 Percentage of participants	33.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Neutrophils, Segmented AH	5.4 Percentage of participants	4.3 Percentage of participants	6.5 Percentage of participants	6.5 Percentage of participants	4.2 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Neutrophils,Segmented AL	30.1 Percentage of participants	23.9 Percentage of participants	18.9 Percentage of participants	26.4 Percentage of participants	17.4 Percentage of participants	20.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Neutrophils,Segmented AH	3.2 Percentage of participants	4.3 Percentage of participants	2.2 Percentage of participants	2.3 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Reticulocytes AL	34.1 Percentage of participants	27.2 Percentage of participants	26.4 Percentage of participants	24.7 Percentage of participants	41.3 Percentage of participants	37.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Reticulocytes AH	4.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Reticulocytes AL	27.2 Percentage of participants	32.6 Percentage of participants	24.4 Percentage of participants	20.9 Percentage of participants	30.4 Percentage of participants	13.6 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Reticulocytes AH	3.3 Percentage of participants	4.3 Percentage of participants	4.4 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Hematocrit AL	7.5 Percentage of participants	10.6 Percentage of participants	14.0 Percentage of participants	8.7 Percentage of participants	10.4 Percentage of participants	13.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Hematocrit AH	1.1 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	2.1 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U: Hematocrit AH	1.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Lymphocytes Atypical AH	80.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Lymphocytes Atypical AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C HGB Conc. AH	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Basophils AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Ery. M.C HGB Conc. AH	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C Hemoglobin AH	7.5 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	6.3 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U::Ery. M.C Hemoglobin AL	7.5 Percentage of participants	8.7 Percentage of participants	6.7 Percentage of participants	8.0 Percentage of participants	2.2 Percentage of participants	6.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) DB:Ery. M.C Volume AL	3.2 Percentage of participants	4.3 Percentage of participants	7.5 Percentage of participants	6.5 Percentage of participants	6.3 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Ery. M.C Volume AL	4.3 Percentage of participants	6.5 Percentage of participants	7.8 Percentage of participants	6.9 Percentage of participants	2.2 Percentage of participants	4.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:LymphocyteAtypical/Leukocyte AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Metamyelocytes AL	0 Percentage of participants	—	—	—	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Metamyelocytes AH	100.0 Percentage of participants	—	—	—	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Monocytes AH	0 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Myelocytes AL	0 Percentage of participants	—	0 Percentage of participants	—	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) F-U:Myelocytes AH	100.0 Percentage of participants	—	100.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and "N" (number of participants analyzed) represents number of participants evaluable for this outcome measure.

Percentage of participants with abnormalities in clinical laboratory tests (Chemistry: abnormally high and serum alpha fetoprotein, serum chloride, Serum gamma glutamyl tranferase \[GGT\], Serum high density cholesterol \[HDL\] Cholesterol, Indirect Bilirubin, Lactate Dehydrogenase, Serum Protein, Urea Nitrogen) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=96 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Indirect Bilirubin AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Indirect Bilirubin AH	6.5 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	8.0 Percentage of participants	6.5 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum Alpha Fetoprotein AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum AlphaFetoprotein AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum Chloride AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum Chloride AH	1.1 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum GGT AL	1.1 Percentage of participants	3.1 Percentage of participants	5.4 Percentage of participants	8.6 Percentage of participants	2.1 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum GGT AH	10.8 Percentage of participants	3.1 Percentage of participants	3.2 Percentage of participants	2.2 Percentage of participants	6.3 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum GGT AL	1.1 Percentage of participants	3.2 Percentage of participants	3.3 Percentage of participants	9.1 Percentage of participants	8.7 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum GGT AH	4.3 Percentage of participants	2.1 Percentage of participants	6.7 Percentage of participants	3.4 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum HDL Cholesterol AL	6.5 Percentage of participants	18.8 Percentage of participants	24.7 Percentage of participants	28.0 Percentage of participants	8.3 Percentage of participants	37.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum HDL Cholesterol AH	50.5 Percentage of participants	15.6 Percentage of participants	11.8 Percentage of participants	6.5 Percentage of participants	41.7 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum HDL Cholesterol AL	18.1 Percentage of participants	20.2 Percentage of participants	15.6 Percentage of participants	28.4 Percentage of participants	19.6 Percentage of participants	17.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum HDL Cholesterol AH	23.4 Percentage of participants	12.8 Percentage of participants	10.0 Percentage of participants	8.0 Percentage of participants	19.6 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Lactate Dehydrogenase AH	6.5 Percentage of participants	7.4 Percentage of participants	7.8 Percentage of participants	9.1 Percentage of participants	13.0 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum Protein AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum Protein AH	4.3 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	2.3 Percentage of participants	2.2 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Urea Nitrogen AL	6.50 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Urea Nitrogen AH	6.5 Percentage of participants	4.2 Percentage of participants	3.2 Percentage of participants	5.4 Percentage of participants	6.3 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Urea Nitrogen AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum Alpha Fetoprotein AH	1.1 Percentage of participants	3.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Serum AlphaFetoprotein AH	1.1 Percentage of participants	2.4 Percentage of participants	0 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Indirect Bilirubin AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Indirect Bilirubin AH	7.5 Percentage of participants	3.1 Percentage of participants	4.3 Percentage of participants	6.5 Percentage of participants	8.3 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Lactate Dehydrogenase AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Lactate Dehydrogenase AH(	9.7 Percentage of participants	11.7 Percentage of participants	3.2 Percentage of participants	8.7 Percentage of participants	14.6 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Lactate Dehydrogenase AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum Protein AL	5.4 Percentage of participants	3.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) DB:Serum Protein AH	2.2 Percentage of participants	3.1 Percentage of participants	4.3 Percentage of participants	3.2 Percentage of participants	7 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) F-U:Urea Nitrogen AH	6.4 Percentage of participants	4.3 Percentage of participants	2.2 Percentage of participants	1.1 Percentage of participants	8.7 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and "N" (number of participants analyzed) represents number of participants evaluable for this outcome measure. Here 'n=0' signifies no participants were available for analysis at specified timepoint.

Percentage of participants with abnormalities in clinical laboratory tests(Urinalysis: abnormally high and low urine granular casts, urine hyaline casts, Urine Leukocytes,Urine Specific Gravity,Urine Squamous Epithelial cell, Urine T.E Cells, Urine Transitinoal erythrocyte count \[E.C\],Urine Tubular erthrocyte count ) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=61 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=61 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=53 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=54 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=29 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=25 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Hyaline Casts AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Hyaline Casts AH	100.0 Percentage of participants	60.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Leukocytes AH	8.5 Percentage of participants	6.3 Percentage of participants	9.5 Percentage of participants	2.6 Percentage of participants	9.5 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Leukocytes AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Specific Gravity AL	1.6 Percentage of participants	0 Percentage of participants	3.8 Percentage of participants	3.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Specific Gravity AH	1.6 Percentage of participants	11.5 Percentage of participants	1.9 Percentage of participants	5.6 Percentage of participants	3.4 Percentage of participants	24.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Specific Gravity AH	5.9 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Squamous Epithelial cell AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Squamous Epithelial cellAH	100.0 Percentage of participants	66.7 Percentage of participants	75.0 Percentage of participants	50.0 Percentage of participants	50.0 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine T.E Cells AL	—	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Transitinoal E.C AH	—	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Granular Casts AL	0 Percentage of participants	—	—	0 Percentage of participants	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Granular Casts AH	100.0 Percentage of participants	—	—	100.0 Percentage of participants	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Hyaline Casts AL	0 Percentage of participants	—	—	—	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Hyaline Casts AH	100.0 Percentage of participants	—	—	—	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Leukocytes AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Leukocytes AH	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	25.0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) F-U:Urine Specific Gravity AL	5.9 Percentage of participants	0 Percentage of participants	5.6 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Tubular E.C AL	—	—	—	0 Percentage of participants	—	—
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) DB:Urine Tubular E.C AH	—	—	—	100.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of participant analysed) signifies number of participant who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participant evaluable for specified categories.

Percentage of participants with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): \<45 beats per minute (bpm); PR interval AH:\>220 msec; QRS duration AH:\>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to \<=480 msec. Participants with abnormally low or high values were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=93 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=95 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=47 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) FU Phase: Heart Rate AL	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) DB Phase: PR interval AH	1.1 Percentage of participants	0 Percentage of participants	3.3 Percentage of participants	1.1 Percentage of participants	4.3 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) FU Phase: PR interval AH	0 Percentage of participants	0 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) DB Phase: QRS duration AH	2.2 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) FU Phase: QTcF interval BP-QT	1.1 Percentage of participants	0 Percentage of participants	2.4 Percentage of participants	1.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) DB Phase: Heart Rate AL	0 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	3.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) FU Phase: QRS duration AH	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Electrocardiogram (ECG) DB Phase: QTcF interval BP-QT	2.2 Percentage of participants	2.1 Percentage of participants	3.3 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants

SECONDARY outcome

Timeframe: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96

Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represented number of participants evaluable for the specified categories.

Percentage of participants with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:\<=45 bpm; Systolic blood pressure (SBP) AL: \<=90 millimeters of mercury (mmHg), mild:\>140 mmHg to \<160 mmHg; moderate:\>=160 mmHg to \<180 mmHg; Diastolic blood pressure (DBP): AL: \<=150 mmHg; mild:\>90 mmHg to \<100 mmHg; moderate: \>=100 mmHg to \<110 mmHg; severe:\>=110 mmHg. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=96 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=93 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Abnormalities in Vital Signs DB:Pulse rate AL	1.1 Percentage of participants	4.2 Percentage of participants	2.2 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB:Pulse rate AH	0 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU:Pulse rate AL	1.1 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	2.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU:Pulse rate AH	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: DBP AL	4.3 Percentage of participants	1.0 Percentage of participants	4.3 Percentage of participants	4.3 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: DBP mild	20.4 Percentage of participants	18.8 Percentage of participants	12.9 Percentage of participants	14.0 Percentage of participants	0 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: DBP moderate	4.3 Percentage of participants	4.2 Percentage of participants	3.2 Percentage of participants	3.2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: DBP severe	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: DBP AL	1.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: DBP mild	10.16 Percentage of participants	10.16 Percentage of participants	4.4 Percentage of participants	12.5 Percentage of participants	0 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: DBP moderate	1.1 Percentage of participants	2.1 Percentage of participants	4.4 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: SBP AL	0 Percentage of participants	6.3 Percentage of participants	2.2 Percentage of participants	6.5 Percentage of participants	0 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: SBP mild	23.7 Percentage of participants	18.8 Percentage of participants	12.9 Percentage of participants	22.6 Percentage of participants	0 Percentage of participants	17.8 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs DB: SBP moderate	4.3 Percentage of participants	3.1 Percentage of participants	4.3 Percentage of participants	2.2 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: SBP AL	3.2 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	4.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: SBP mild	12.8 Percentage of participants	12.8 Percentage of participants	11.1 Percentage of participants	10.2 Percentage of participants	0 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Abnormalities in Vital Signs FU: SBP moderate	0 Percentage of participants	2.1 Percentage of participants	2.2 Percentage of participants	2.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: mITT set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.

Percentage of participants with HBsAg seroclearance 24 weeks after completion of all study intervention at Week 48 were reported. HBsAg seroclearance was defined as HBsAg (less than \[\<\] lower limit of quantification LLOQ \[0.05 IU/mL\]). Responder was defined as a participant who achieved functional cure at Week 72. A participant was defined as having achieved functional cure at Week 72 if he/she: had met the criteria for stopping NA treatment at Week 48 and stopped treatment; had HBsAg seroclearance at Week 72 (that is, 24 weeks after stopping all study interventions); did not require NA re-treatment between Weeks 48 and 72. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48	0.0 Percentage of participants Interval 0.0 to 3.14	0.0 Percentage of participants Interval 0.0 to 3.14	0.0 Percentage of participants Interval 0.0 to 3.2	0.0 Percentage of participants Interval 0.0 to 3.24	0.0 Percentage of participants Interval 0.0 to 6.05	2.2 Percentage of participants Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Week 96

Population: mITT analysis set included all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.

Percentage of participants with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg \<LLOQ (0.05 IU/mL). A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 3.14	1.1 Percentage of participants 90% Confidence Interval 0.05 • Interval 0.05 to 4.95	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 3.2	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 3.24	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.05	2.2 Percentage of participants 90% Confidence Interval 0.11 • Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Weeks 72 and 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Percentage of participants with HBV DNA \<LLOQ at 24 and 48 weeks after completion of all study intervention at Week 48 were reported. A responder was defined as a participant who achieved HBV DNA \<LLOQ 24 and 48 weeks after stopping all study treatments at any time during the study and without restarting NA treatment thereafter.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 Week 96	6.4 Percentage of participants Interval 2.82 to 12.21	9.6 Percentage of participants Interval 5.09 to 16.11	5.4 Percentage of participants Interval 2.17 to 11.09	1.1 Percentage of participants Interval 0.06 to 5.11	2.1 Percentage of participants Interval 0.11 to 9.51	0.0 Percentage of participants Interval 0.0 to 6.44
Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 Week 72	5.3 Percentage of participants Interval 2.12 to 10.86	16.0 Percentage of participants Interval 10.1 to 23.5	7.6 Percentage of participants Interval 3.63 to 13.82	1.1 Percentage of participants Interval 0.06 to 5.11	0.0 Percentage of participants Interval 0.0 to 6.05	4.4 Percentage of participants Interval 0.8 to 13.34

SECONDARY outcome

Timeframe: Week 48 up to Week 96

Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.

Percentage of participants meeting the NA treatment completion criteria during follow-up were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). A responder was defined as a participant who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up	11.7 Percentage of participants Interval 6.7 to 18.63	27.7 Percentage of participants Interval 20.16 to 36.25	16.3 Percentage of participants Interval 10.33 to 23.99	4.4 Percentage of participants Interval 1.52 to 9.78	0.0 Percentage of participants Interval 0.0 to 6.05	2.2 Percentage of participants Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Weeks 60, 84, and 96

Percentage of participants with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84, and 96 were reported. Seroclearance of HBsAg was defined as HBsAg level \<LLOQ (0.05 IU/mL). For Week 60: a responder was defined as a participant who achieved HBsAg seroclearance 12 weeks off treatment if the subject achieved HBsAg seroclearance 12 weeks after stopping; for Week 84:A responder was defined as a participant who achieved HBsAg seroclearance 36 weeks off-treatment if the participant achieved HBsAg seroclearance 36 weeks after stopping all study treatments; for Week 96:A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 Week 60	0.0 Percentage of of participants Interval 0.0 to 28.31	9.1 Percentage of of participants Interval 1.64 to 25.95	0.0 Percentage of of participants Interval 0.0 to 15.33	0.0 Percentage of of participants Interval 0.0 to 45.07	—	0.0 Percentage of of participants Interval 0.0 to 95.0
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 Week 84	0.0 Percentage of of participants Interval 0.0 to 25.89	9.1 Percentage of of participants Interval 1.64 to 25.95	0.0 Percentage of of participants Interval 0.0 to 19.26	0.0 Percentage of of participants Interval 0.0 to 45.07	—	100.0 Percentage of of participants Interval 5.0 to 100.0
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 Week 96	0.0 Percentage of of participants Interval 0.0 to 3.14	1.1 Percentage of of participants Interval 0.05 to 4.95	0.0 Percentage of of participants Interval 0.0 to 3.2	0.0 Percentage of of participants Interval 0.0 to 3.24	0.0 Percentage of of participants Interval 0.0 to 6.05	2.2 Percentage of of participants Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Week 48 up to Week 96

Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participant impacted by the pandemic defined as those participant who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.

Percentage of participants who required NA re-treatment during follow-up were reported. Responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. NA re-treatment criteria: (1) Re-start NA treatment immediately with signs of decreasing liver function based on laboratory findings (eg, International Normalized Ratio \[INR\], direct bilirubin) or clinical assessment (eg, ascites, hepatic encephalopathy). (2) Immediately with an HBV DNA value of \>100,000 IU/mL (irrespective of confirmation and/or ALT increase). (3) With confirmed post-treatment HBeAg seroreversion (HBeAg positive after it was negative at NA completion) (4) With confirmed\* post-treatment increases in HBV DNA \>2,000 IU/mL and ALT \>5x ULN (5) With confirmed\* post-treatment increases in HBV DNA \>20,000 IU/mL.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants Who Required NA Re-treatment During Follow-up	1.1 Percentage of participants 90% Confidence Interval 0.05 • Interval 0.05 to 4.95	1.1 Percentage of participants 90% Confidence Interval 0.05 • Interval 0.05 to 4.95	2.2 Percentage of participants 90% Confidence Interval 0.39 • Interval 0.39 to 6.69	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 3.24	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.05	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.44

SECONDARY outcome

Timeframe: Follow-up phase (Week 48 up to Week 96)

Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of participants evaluable for the specified categories.

Percentage of participants with flares (virologic, biochemical, and clinical) were reported. Virologic flare: confirmed HBV DNA \>peak threshold ( 20,000 IU/mL 2,000 IU/mL and 200 IU/mL); biochemical Flare: confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir; clinical flare: confirmed HBV DNA \>peak threshold and confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir. Virologic and clinical flare was assessed only for those participants who were off-treatment and had HBV DNA\<LLOQ at the last observed time point on all study treatments and biochemical flares was identified on treatment and off treatment, respectively. Each virologic flare was categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds within the start and end date of that flare as follows: 20,000 IU/mL 2,000 IU/mL and 200 IU/mL. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Flares Biochemical: On NA	0.0 Percentage of participants Interval 0.0 to 3.14	0.0 Percentage of participants Interval 0.0 to 3.14	0.0 Percentage of participants Interval 0.0 to 3.2	0.0 Percentage of participants Interval 0.0 to 3.24	2.1 Percentage of participants Interval 0.11 to 9.51	0.0 Percentage of participants Interval 0.0 to 6.44
Percentage of Participants With Flares Biochemical: Off NA	0.0 Percentage of participants Interval 0.0 to 8.68	2.5 Percentage of participants Interval 1.13 to 11.32	0.0 Percentage of participants Interval 0.0 to 7.22	0.0 Percentage of participants Interval 0.0 to 14.59	0.0 Percentage of participants Interval 0.0 to 25.89	0.0 Percentage of participants Interval 0.0 to 25.89
Percentage of Participants With Flares Clinical HBVDNA>2000:Off NA	0.0 Percentage of participants Interval 0.0 to 9.5	0.0 Percentage of participants Interval 0.0 to 7.78	0.0 Percentage of participants Interval 0.0 to 7.78	0.0 Percentage of participants Interval 0.0 to 19.26	0.0 Percentage of participants Interval 0.0 to 28.31	0.0 Percentage of participants Interval 0.0 to 25.89
Percentage of Participants With Flares Virologic HBVDNA>200:Off NA	13.3 Percentage of participants Interval 4.69 to 27.96	24.3 Percentage of participants Interval 13.32 to 38.61	21.6 Percentage of participants Interval 11.24 to 35.64	14.3 Percentage of participants Interval 2.6 to 38.54	0.0 Percentage of participants Interval 0.0 to 28.31	0.0 Percentage of participants Interval 0.0 to 25.89
Percentage of Participants With Flares Virologic HBVDNA>2000:Off NA	3.3 Percentage of participants Interval 0.17 to 14.86	2.7 Percentage of participants Interval 0.14 to 12.19	8.1 Percentage of participants Interval 2.25 to 19.64	7.1 Percentage of participants Interval 0.37 to 29.67	0.0 Percentage of participants Interval 0.0 to 28.21	10.0 Percentage of participants Interval 0.51 to 39.42
Percentage of Participants With Flares Clinical HBVDNA>20000:Off NA	0.0 Percentage of participants Interval 0.0 to 9.5	2.7 Percentage of participants Interval 0.14 to 12.19	0.0 Percentage of participants Interval 0.0 to 7.78	0.0 Percentage of participants Interval 0.0 to 19.26	0.0 Percentage of participants Interval 0.0 to 28.31	0.0 Percentage of participants Interval 0.0 to 25.89
Percentage of Participants With Flares Virologic HBVDNA>20000:Off NA	3.0 Percentage of participants Interval 0.17 to 14.86	2.7 Percentage of participants Interval 0.14 to 12.19	5.4 Percentage of participants Interval 0.97 to 16.05	0.0 Percentage of participants Interval 0.0 to 19.26	0.0 Percentage of participants Interval 0.0 to 8.31	0.0 Percentage of participants Interval 0.0 to 25.89
Percentage of Participants With Flares Clinical HBVDNA>200:Off NA	0.0 Percentage of participants Interval 0.0 to 9.5	0.0 Percentage of participants Interval 0.0 to 7.78	0.0 Percentage of participants Interval 0.0 to 7.78	0.0 Percentage of participants Interval 0.0 to 19.26	0.0 Percentage of participants Interval 0.0 to 28.31	0.0 Percentage of participants Interval 0.0 to 25.89

SECONDARY outcome

Timeframe: Weeks 12, 24, 36 and 48

Population: mITT population. Here, 'N' (number of participants analyzed) signifies number of participants with non-missing data for both blood markers at specified time point after stopping all study treatments (including NA), who also met NA treatment completion criteria and at least 24 week off-treatment data available; and 'n' (number analysed) represents number of participants evaluable at specified timepoints.

Number of participants with (sustained) reduction considering multiple markers were reported. HBV DNA results \<LLOQ were reported as: (a) target detected, that is, traces of HBV DNA were detected/found but were too low to be quantified, or (b) target not detected, that is, no traces of HBV DNA were detected/found. LLOQ value for HBV DNA was 20 IU/mL.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=10 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=25 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=18 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=1 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=1 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected	6 Participants	7 Participants	5 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected	6 Participants	20 Participants	7 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected	4 Participants	13 Participants	6 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected	3 Participants	8 Participants	7 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 48, 60, 72, and 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg \[quantitative\] \<LLOQ \[0.05 IU/mL\]) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies \[quantitative\] \<LLOQ and a post-baseline assessment greater than or equal to \[\>=\] LLOQ).

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=87 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=89 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=83 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=85 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=42 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Seroconversion Week 48	0.0 Percentage of participants	1.1 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With HBsAg Seroconversion Week 60	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With HBsAg Seroconversion Week 72	0.0 Percentage of participants	0.0 Percentage of participants	1.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	2.4 Percentage of participants
Percentage of Participants With HBsAg Seroconversion Week 96	0.0 Percentage of participants	1.2 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 48, 60, 72, and 96

Population: mITT population. Here, 'N' (number of participants analyzed) signifies HbeAg positive participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg \[quantitative\] \<LLOQ) together with an appearance of anti-HBe antibodies (baseline anti-HBe antibodies \[qualitative\] with a "negative" result and a post-baseline assessment with "positive" result.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=25 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=28 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=23 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=25 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=14 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=11 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBeAg Seroconversion Week 96	8.0 Percentage of participants	14.8 Percentage of participants	13.0 Percentage of participants	4.2 Percentage of participants	7.7 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With HBeAg Seroconversion Week 48	4.0 Percentage of participants	3.6 Percentage of participants	8.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	18.2 Percentage of participants
Percentage of Participants With HBeAg Seroconversion Week 60	4.3 Percentage of participants	7.4 Percentage of participants	4.5 Percentage of participants	0 Percentage of participants	0 Percentage of participants	20.0 Percentage of participants
Percentage of Participants With HBeAg Seroconversion Week 72	4.2 Percentage of participants	3.7 Percentage of participants	9.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	18.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Change from baseline in HBsAg levels was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Change From Baseline in HBsAg Levels Baseline	3.66 Log10 international units per milliliter Standard Deviation 0.691	3.83 Log10 international units per milliliter Standard Deviation 0.721	3.70 Log10 international units per milliliter Standard Deviation 0.778	3.81 Log10 international units per milliliter Standard Deviation 0.678	3.63 Log10 international units per milliliter Standard Deviation 0.681	3.83 Log10 international units per milliliter Standard Deviation 0.714
Change From Baseline in HBsAg Levels Week 12	-0.96 Log10 international units per milliliter Standard Deviation 0.533	-1.51 Log10 international units per milliliter Standard Deviation 0.790	-1.24 Log10 international units per milliliter Standard Deviation 0.646	-0.82 Log10 international units per milliliter Standard Deviation 0.361	-0.01 Log10 international units per milliliter Standard Deviation 0.286	-0.07 Log10 international units per milliliter Standard Deviation 0.244
Change From Baseline in HBsAg Levels Week 24	-1.52 Log10 international units per milliliter Standard Deviation 0.582	-2.22 Log10 international units per milliliter Standard Deviation 0.768	-1.84 Log10 international units per milliliter Standard Deviation 0.612	-1.26 Log10 international units per milliliter Standard Deviation 0.430	-0.05 Log10 international units per milliliter Standard Deviation 0.356	-0.12 Log10 international units per milliliter Standard Deviation 0.350
Change From Baseline in HBsAg Levels Week 60	-1.59 Log10 international units per milliliter Standard Deviation 0.613	-2.21 Log10 international units per milliliter Standard Deviation 0.975	-1.75 Log10 international units per milliliter Standard Deviation 0.699	-1.22 Log10 international units per milliliter Standard Deviation 0.456	-0.12 Log10 international units per milliliter Standard Deviation 0.367	-0.21 Log10 international units per milliliter Standard Deviation 0.747
Change From Baseline in HBsAg Levels Week 48	-1.76 Log10 international units per milliliter Standard Deviation 0.643	-2.58 Log10 international units per milliliter Standard Deviation 0.996	-2.09 Log10 international units per milliliter Standard Deviation 0.665	-1.50 Log10 international units per milliliter Standard Deviation 0.470	-0.07 Log10 international units per milliliter Standard Deviation 0.354	-0.22 Log10 international units per milliliter Standard Deviation 0.854
Change From Baseline in HBsAg Levels Week 72	-1.38 Log10 international units per milliliter Standard Deviation 0.630	-1.85 Log10 international units per milliliter Standard Deviation 0.927	-1.50 Log10 international units per milliliter Standard Deviation 0.783	-1.01 Log10 international units per milliliter Standard Deviation 0.487	-0.15 Log10 international units per milliliter Standard Deviation 0.366	-0.26 Log10 international units per milliliter Standard Deviation 1.032
Change From Baseline in HBsAg Levels Week 96	-1.04 Log10 international units per milliliter Standard Deviation 0.634	-1.39 Log10 international units per milliliter Standard Deviation 0.895	-1.15 Log10 international units per milliliter Standard Deviation 0.744	-0.74 Log10 international units per milliliter Standard Deviation 0.497	-0.14 Log10 international units per milliliter Standard Deviation 0.360	-0.25 Log10 international units per milliliter Standard Deviation 1.031

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Population: mITT analysis set: all HbeAg + participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Change from baseline in HBeAg levels was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=27 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=30 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=25 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=30 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=15 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=13 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Change From Baseline in HBeAg Levels Week 24	-1.00 log10 IU/mL Standard Deviation 0.880	-1.17 log10 IU/mL Standard Deviation 0.832	-1.12 log10 IU/mL Standard Deviation 0.636	-0.54 log10 IU/mL Standard Deviation 0.372	-0.77 log10 IU/mL Standard Deviation 0.817	-0.59 log10 IU/mL Standard Deviation 0.782
Change From Baseline in HBeAg Levels Week 48	-1.43 log10 IU/mL Standard Deviation 1.194	-1.50 log10 IU/mL Standard Deviation 1.142	-1.53 log10 IU/mL Standard Deviation 0.999	-0.78 log10 IU/mL Standard Deviation 0.550	-0.84 log10 IU/mL Standard Deviation 0.876	-0.96 log10 IU/mL Standard Deviation 1.325
Change From Baseline in HBeAg Levels Week 60	-1.40 log10 IU/mL Standard Deviation 1.253	-1.61 log10 IU/mL Standard Deviation 1.168	-1.32 log10 IU/mL Standard Deviation 0.763	-0.83 log10 IU/mL Standard Deviation 0.600	-0.87 log10 IU/mL Standard Deviation 0.874	-1.03 log10 IU/mL Standard Deviation 1.384
Change From Baseline in HBeAg Levels Baseline	1.22 log10 IU/mL Standard Deviation 1.494	1.60 log10 IU/mL Standard Deviation 1.449	1.68 log10 IU/mL Standard Deviation 1.540	1.26 log10 IU/mL Standard Deviation 1.318	0.81 log10 IU/mL Standard Deviation 1.261	1.03 log10 IU/mL Standard Deviation 1.435
Change From Baseline in HBeAg Levels Week 12	-0.82 log10 IU/mL Standard Deviation 0.746	-0.90 log10 IU/mL Standard Deviation 0.629	-0.95 log10 IU/mL Standard Deviation 0.502	-0.44 log10 IU/mL Standard Deviation 0.273	-0.60 log10 IU/mL Standard Deviation 0.652	-0.32 log10 IU/mL Standard Deviation 0.425
Change From Baseline in HBeAg Levels Week 72	-1.50 log10 IU/mL Standard Deviation 1.276	-1.67 log10 IU/mL Standard Deviation 1.303	-1.44 log10 IU/mL Standard Deviation 1.000	-0.80 log10 IU/mL Standard Deviation 0.687	-0.95 log10 IU/mL Standard Deviation 0.891	-0.97 log10 IU/mL Standard Deviation 1.361
Change From Baseline in HBeAg Levels Week 96	-1.55 log10 IU/mL Standard Deviation 1.334	-1.58 log10 IU/mL Standard Deviation 1.325	-1.43 log10 IU/mL Standard Deviation 1.092	-0.84 log10 IU/mL Standard Deviation 0.710	-1.21 log10 IU/mL Standard Deviation 1.104	-1.07 log10 IU/mL Standard Deviation 1.357

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Change from baseline in HBV DNA levels were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=33 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=35 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=33 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=33 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=18 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=16 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Change From Baseline in HBV DNA Levels Baseline	5.97 log10 IU/mL Standard Deviation 1.989	6.64 log10 IU/mL Standard Deviation 1.972	6.34 log10 IU/mL Standard Deviation 1.778	6.10 log10 IU/mL Standard Deviation 1.916	6.48 log10 IU/mL Standard Deviation 2.008	6.39 log10 IU/mL Standard Deviation 1.922
Change From Baseline in HBV DNA Levels Week 12	-4.13 log10 IU/mL Standard Deviation 1.267	-3.90 log10 IU/mL Standard Deviation 1.221	-3.83 log10 IU/mL Standard Deviation 1.079	-3.72 log10 IU/mL Standard Deviation 1.008	-4.28 log10 IU/mL Standard Deviation 1.052	-3.64 log10 IU/mL Standard Deviation 1.365
Change From Baseline in HBV DNA Levels Week 24	-4.59 log10 IU/mL Standard Deviation 1.532	-5.03 log10 IU/mL Standard Deviation 1.441	-4.68 log10 IU/mL Standard Deviation 1.199	-4.53 log10 IU/mL Standard Deviation 1.273	-5.08 log10 IU/mL Standard Deviation 1.566	-4.34 log10 IU/mL Standard Deviation 1.457
Change From Baseline in HBV DNA Levels Week 60	-4.85 log10 IU/mL Standard Deviation 1.910	-5.39 log10 IU/mL Standard Deviation 1.673	-5.27 log10 IU/mL Standard Deviation 1.759	-4.95 log10 IU/mL Standard Deviation 1.602	-5.40 log10 IU/mL Standard Deviation 1.808	-4.67 log10 IU/mL Standard Deviation 2.028
Change From Baseline in HBV DNA Levels Week 96	-4.96 log10 IU/mL Standard Deviation 2.010	-5.45 log10 IU/mL Standard Deviation 1.948	-5.18 log10 IU/mL Standard Deviation 2.004	-5.06 log10 IU/mL Standard Deviation 1.693	-5.63 log10 IU/mL Standard Deviation 1.827	-4.95 log10 IU/mL Standard Deviation 1.963
Change From Baseline in HBV DNA Levels Week 48	-4.85 log10 IU/mL Standard Deviation 1.896	-5.28 log10 IU/mL Standard Deviation 1.663	-5.18 log10 IU/mL Standard Deviation 1.669	-4.86 log10 IU/mL Standard Deviation 1.605	-5.71 log10 IU/mL Standard Deviation 1.578	-4.68 log10 IU/mL Standard Deviation 1.970
Change From Baseline in HBV DNA Levels Week 72	-4.97 log10 IU/mL Standard Deviation 1.912	-5.40 log10 IU/mL Standard Deviation 1.849	-5.25 log10 IU/mL Standard Deviation 1.727	-5.04 log10 IU/mL Standard Deviation 1.606	-5.49 log10 IU/mL Standard Deviation 1.845	-4.81 log10 IU/mL Standard Deviation 1.903

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT set: participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. N (number of participants analyzed): participants who achieved seroclearance and were available for the analysis and '0' in the number of participants analyzed field signifies none of the participant achieved seroclearance.

Time to HBsAg seroclearance (defined as HBsAg level \<LLOQ \[0.05 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=3 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=1 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Time to Achieve HBsAg Seroclearance	—	NA Weeks Here "NA" signifies that median and 90% confidence interval (CI) could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median and 90% CI could not be calculated due to insufficient number of participants with events.	—	—	NA Weeks Here "NA" signifies that median and 90% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'Here, 'N' (number of participants analyzed) signifies HBeAg positive participants who achieved seroclearance and were available for the analysis

Time to HBeAg seroclearance (defined as HBeAg level \<LLOQ \[0.11 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBeAg seroclearance.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=6 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=5 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=7 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=3 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=4 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=2 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Time to Achieve HBeAg Seroclearance	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% confidence interval (CI) could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.	NA Weeks Here "NA" signifies that median, lower and upper limit of 90% CI could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Percentage of participants with HBsAg levels \<100 IU/mL was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Levels <100 IU/mL Baseline	0 Percentage of participants	1.1 Percentage of participants	1.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 12	19.6 Percentage of participants	33.7 Percentage of participants	30.2 Percentage of participants	15.9 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 24	42.9 Percentage of participants	65.2 Percentage of participants	59.1 Percentage of participants	25.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 48	57.5 Percentage of participants	74.7 Percentage of participants	69.3 Percentage of participants	36.0 Percentage of participants	0 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 60	54.0 Percentage of participants	61.2 Percentage of participants	56.0 Percentage of participants	22.9 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 72	43.5 Percentage of participants	47.0 Percentage of participants	37.8 Percentage of participants	14.3 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With HBsAg Levels <100 IU/mL Week 96	21.3 Percentage of participants	35.4 Percentage of participants	28.2 Percentage of participants	9.8 Percentage of participants	0 Percentage of participants	2.2 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 60, 72, 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Percentage of participants with HBsAg levels \>1 log10 IU/mL reduction from baseline was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=92 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=88 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=88 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=46 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 96	41.6 Percentage of partcipants	63.4 Percentage of partcipants	49.4 Percentage of partcipants	20.7 Percentage of partcipants	4.5 Percentage of partcipants	4.4 Percentage of partcipants
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 12	40.2 Percentage of partcipants	72.8 Percentage of partcipants	60.5 Percentage of partcipants	27.3 Percentage of partcipants	2.2 Percentage of partcipants	0 Percentage of partcipants
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 24	84.6 Percentage of partcipants	97.8 Percentage of partcipants	93.2 Percentage of partcipants	71.6 Percentage of partcipants	4.4 Percentage of partcipants	4.5 Percentage of partcipants
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 48	93.1 Percentage of partcipants	97.8 Percentage of partcipants	97.7 Percentage of partcipants	82.6 Percentage of partcipants	4.4 Percentage of partcipants	4.5 Percentage of partcipants
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 60	86.2 Percentage of partcipants	94.1 Percentage of partcipants	90.5 Percentage of partcipants	67.5 Percentage of partcipants	4.3 Percentage of partcipants	4.4 Percentage of partcipants
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline Week 72	71.8 Percentage of partcipants	84.4 Percentage of partcipants	73.2 Percentage of partcipants	46.6 Percentage of partcipants	4.3 Percentage of partcipants	6.7 Percentage of partcipants

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 60, 72, 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Percentage of HBeAg-positive participants with HBeAg levels \<LLOQ were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=27 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=29 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=25 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=30 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=15 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=13 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 12	7.4 Percentage of participants	3.7 Percentage of participants	17.4 Percentage of participants	6.9 Percentage of participants	7.7 Percentage of participants	0 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 60	12.0 Percentage of participants	11.1 Percentage of participants	16.7 Percentage of participants	7.4 Percentage of participants	6.7 Percentage of participants	16.7 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 72	8.0 Percentage of participants	11.1 Percentage of participants	21.7 Percentage of participants	10.7 Percentage of participants	6.7 Percentage of participants	15.4 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 24	7.4 Percentage of participants	3.4 Percentage of participants	16.0 Percentage of participants	6.7 Percentage of participants	7.7 Percentage of participants	0 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 48	19.2 Percentage of participants	7.1 Percentage of participants	20.8 Percentage of participants	11.1 Percentage of participants	7.1 Percentage of participants	15.4 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ Week 96	15.4 Percentage of participants	14.8 Percentage of participants	20.8 Percentage of participants	11.5 Percentage of participants	21.4 Percentage of participants	15.4 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 60, 72, 96

Population: mITT population. Here, 'N' (number of participants analyzed) signifies HBeAg + participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Percentage of HBeAg-positive partcipants with HBeAg levels \>1 log10 IU/mL were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=27 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=29 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=25 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=30 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=15 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=13 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 60	52.0 Percentage of participants	63.3 Percentage of participants	62.5 Percentage of participants	37.0 Percentage of participants	40.0 Percentage of participants	33.3 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 72	56.0 Percentage of participants	59.3 Percentage of participants	65.2 Percentage of participants	35.7 Percentage of participants	40.0 Percentage of participants	30.8 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 12	33.3 Percentage of participants	33.3 Percentage of participants	39.1 Percentage of participants	3.4 Percentage of participants	23.1 Percentage of participants	10.0 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 24	44.4 Percentage of participants	48.3 Percentage of participants	60.0 Percentage of participants	10.0 Percentage of participants	30.8 Percentage of participants	23.1 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 48	50.0 Percentage of participants	53.6 Percentage of participants	66.7 Percentage of participants	25.9 Percentage of participants	35.7 Percentage of participants	30.8 Percentage of participants
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL Week 96	53.8 Percentage of participants	59.3 Percentage of participants	58.3 Percentage of participants	42.3 Percentage of participants	42.9 Percentage of participants	30.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Percentage of participants with HBV DNA levels \<LLOQ (20 IU/mL) were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With HBV DNA Levels <LLOQ Week 12	78.3 Percentage of participants	71.7 Percentage of participants	76.7 Percentage of participants	70.5 Percentage of participants	73.3 Percentage of participants	75.6 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Baseline	64.4 Percentage of participants	60.4 Percentage of participants	63.7 Percentage of participants	60.9 Percentage of participants	60.6 Percentage of participants	63.8 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Week 24	84.6 Percentage of participants	80.4 Percentage of participants	81.8 Percentage of participants	83.0 Percentage of participants	80.0 Percentage of participants	77.3 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Week 48	92.0 Percentage of participants	85.7 Percentage of participants	86.4 Percentage of participants	90.8 Percentage of participants	95.6 Percentage of participants	93.3 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Week 60	88.6 Percentage of participants	85.9 Percentage of participants	79.5 Percentage of participants	85.9 Percentage of participants	93.5 Percentage of participants	93.3 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Week 72	89.5 Percentage of participants	81.2 Percentage of participants	81.9 Percentage of participants	86.9 Percentage of participants	95.7 Percentage of participants	91.1 Percentage of participants
Percentage of Participants With HBV DNA Levels <LLOQ Week 96	94.4 Percentage of participants	75.6 Percentage of participants	80.0 Percentage of participants	87.5 Percentage of participants	95.5 Percentage of participants	93.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants with ALT elevation at baseline who were evaluable for this outcome measure.

Mean change from baseline in ALT at EOT (Week 48) in participants with elevated ALT at baseline were reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=35 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=32 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=37 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=34 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=19 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=18 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline	-72.77 Units per liter (U/L) Standard Deviation 106.851 • Interval 106.851 to	-65.47 Units per liter (U/L) Standard Deviation 110.213 • Interval 110.213 to	-37.51 Units per liter (U/L) Standard Deviation 63.468 • Interval 63.468 to	-42.53 Units per liter (U/L) Standard Deviation 41.767 • Interval 41.767 to	-17.68 Units per liter (U/L) Standard Deviation 272.44 • Interval 272.44 to	-49.28 Units per liter (U/L) Standard Deviation 85.374 • Interval 85.374 to

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 48, 60, 72, 96

Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.

Percentage of participants with ALT normalization was reported. A participant with ALT elevation at baseline was considered to achieve ALT normalization if his/her ALT value was \<ULN at any given postbaseline analysis time point. A participant was defined as on treatment failure if he/she never met the criteria for stopping NA treatment during the study. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=36 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=32 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=37 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=34 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=19 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=18 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With ALT Normalization Week 24 On-treatment	61.8 Percentage of participants	43.3 Percentage of participants	69.4 Percentage of participants	78.8 Percentage of participants	76.5 Percentage of participants	55.6 Percentage of participants
Percentage of Participants With ALT Normalization Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With ALT Normalization Week 12 On-treatment	54.3 Percentage of participants	41.9 Percentage of participants	58.3 Percentage of participants	64.5 Percentage of participants	56.3 Percentage of participants	47.1 Percentage of participants
Percentage of Participants With ALT Normalization Week 48 On-treatment	60.6 Percentage of participants	46.7 Percentage of participants	65.7 Percentage of participants	83.9 Percentage of participants	87.5 Percentage of participants	58.8 Percentage of participants
Percentage of Participants With ALT Normalization Week 60 On-treatment	0 Percentage of participants	3.6 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With ALT Normalization Week 72 On-treatment	0 Percentage of participants	3.6 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With ALT Normalization Week 96 On-treatment	21.2 Percentage of participants	11.5 Percentage of participants	35.3 Percentage of participants	10.0 Percentage of participants	16.7 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With ALT Normalization Week 60 Off-treatment	0 Percentage of participants	3.6 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With ALT Normalization Week 72 Off-treatment	0 Percentage of participants	3.6 Percentage of participants	12.1 Percentage of participants	0 Percentage of participants	0 Percentage of participants	5.6 Percentage of participants
Percentage of Participants With ALT Normalization Week 96 Off-treatment	21.2 Percentage of participants	11.5 Percentage of participants	35.3 Percentage of participants	10.0 Percentage of participants	16.7 Percentage of participants	11.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 48

Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by \>1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ (20 IU/mL). On-treatment was defined as the time period in which the participant received any of the study intervention.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Virologic Breakthrough	2.1 Percentage of participants 90% Confidence Interval 0.38 • Interval 0.38 to 6.55	2.1 Percentage of participants 90% Confidence Interval 0.38 • Interval 0.38 to 6.55	2.2 Percentage of participants 90% Confidence Interval 0.39 • Interval 0.39 to 6.69	2.2 Percentage of participants 90% Confidence Interval 0.39 • Interval 0.39 to 6.76	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.05	2.2 Percentage of participants 90% Confidence Interval 0.11 • Interval 0.11 to 10.11

SECONDARY outcome

Timeframe: Week 48 up to Week 96

Percentage of participants with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=94 Participants Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 2: JNJ-73763989 200 mg + Placebo + NA n=94 Participants Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 3: JNJ-73763989 100 mg + Placebo + NA n=92 Participants Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 4: JNJ-73763989 40 mg + Placebo + NA n=91 Participants Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 5: Placebo + JNJ-56136379 250 mg + NA n=48 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).	Arm 6: Placebo + Placebo + NA n=45 Participants Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48).
Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up	1.1 Percentage of participants 90% Confidence Interval 0.05 • Interval 0.05 to 4.95	1.1 Percentage of participants 90% Confidence Interval 0.05 • Interval 0.05 to 4.95	1.1 Percentage of participants 90% Confidence Interval 0.06 • Interval 0.06 to 5.05	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 3.24	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.05	0.0 Percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 6.44

Adverse Events

Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA

Serious events: 3 serious events

Other events: 59 other events

Deaths: 0 deaths

Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA

Serious events: 1 serious events

Other events: 60 other events

Deaths: 0 deaths

Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Arm 6: DB Phase: Placebo + Placebo + NA

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Arm 6 :Follow up Phase 1: Placebo + Placebo + NA

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 6: Follow up Phase 2: Placebo + Placebo + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 6: Follow up Phase 3: Placebo + Placebo + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 2: Extended Follow Up: JNJ-73763989 (200 mg) + Placebo + NA

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 6: Extended Follow Up: Placebo + Placebo + NA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=95 participants at risk Participants received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks.	Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA n=96 participants at risk Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA n=93 participants at risk Participants received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks.	Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA n=93 participants at risk Participants received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA n=48 participants at risk Participants received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 6: DB Phase: Placebo + Placebo + NA n=45 participants at risk Participants received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=81 participants at risk Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase and did not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA n=70 participants at risk Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA n=71 participants at risk Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA n=85 participants at risk Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA n=47 participants at risk Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 6 :Follow up Phase 1: Placebo + Placebo + NA n=44 participants at risk Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and did not meet NA treatment completion criteria or did Not stop NA were followed up till week 96.	Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=8 participants at risk Participants who received JNJ-73763989 100 mg) along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA n=17 participants at risk Participants who received JNJ-73763989 100 mg along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA n=15 participants at risk Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA n=5 participants at risk Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 6: Follow up Phase 2: Placebo + Placebo + NA n=1 participants at risk Participants who received placebo matching to JNJ-73763989 and placebo matching to JNJ-56136379 along with NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=3 participants at risk Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up followed-up till Week 96.	Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA n=8 participants at risk Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up were followed-up till Week 96.	Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA n=5 participants at risk Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.	Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 6: Follow up Phase 3: Placebo + Placebo + NA Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=3 participants at risk Participants received JNJ-73763989 100 mg along with JNJ-56136379 250 mg NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 2: Extended Follow Up: JNJ-73763989 (200 mg) + Placebo + NA n=7 participants at risk Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA n=5 participants at risk Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA Participants received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA Participants received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 6: Extended Follow Up: Placebo + Placebo + NA Participants received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Melaena	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Cardiac disorders Coronary Artery Disease	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Retinal Detachment	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Gastric Polyps	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Gallbladder Cholesterolosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Appendicitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Covid-19	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Covid-19 Pneumonia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Cystitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Pneumocystis Jirovecii Pneumonia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Urinary Tract Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Fracture Displacement	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Ligament Rupture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Alanine Aminotransferase Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Aspartate Aminotransferase Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	33.3% 1/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Myoclonus	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Renal Colic	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Urinary Incontinence	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.

Other adverse events

Other adverse events
Measure	Arm 1: DB Phase: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA n=95 participants at risk Participants received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks.	Arm 2: DB Phase: JNJ-73763989 200 mg + Placebo + NA n=96 participants at risk Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 3: DB Phase: JNJ-73763989 (100 mg) + Placebo + NA n=93 participants at risk Participants received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks.	Arm 4: DB Phase: JNJ-73763989 (40 mg) + Placebo + NA n=93 participants at risk Participants received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 5: DB Phase: Placebo + JNJ-56136379 250 mg + NA n=48 participants at risk Participants received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 6: DB Phase: Placebo + Placebo + NA n=45 participants at risk Participants received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks.	Arm 1: Follow up Phase 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=81 participants at risk Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase and did not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 2: Follow up Phase 1: JNJ-73763989 (200mg) + Placebo + NA n=70 participants at risk Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 3: Follow up Phase 1: JNJ-73763989 (100 mg) + Placebo + NA n=71 participants at risk Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 4: Follow up Phase 1: JNJ-73763989 (40 mg) + Placebo + NA n=85 participants at risk Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase and Did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 5: Follow up Phase 1: Placebo + JNJ-56136379 250 mg + NA n=47 participants at risk Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and did Not meet NA treatment completion criteria or did not stop NA were followed-up till Week 96.	Arm 6 :Follow up Phase 1: Placebo + Placebo + NA n=44 participants at risk Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and did not meet NA treatment completion criteria or did Not stop NA were followed up till week 96.	Arm 1: Follow up Phase 2: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=8 participants at risk Participants who received JNJ-73763989 100 mg) along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 2: Follow up Phase 2: JNJ-73763989 (200mg) + Placebo + NA n=17 participants at risk Participants who received JNJ-73763989 100 mg along with JNJ-56136379 250 mg and NA up to 48 weeks during double blind period and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 3: Follow up Phase 2: JNJ-73763989 (100 mg) + Placebo + NA n=15 participants at risk Participants who received JNJ-73763989 100 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 4: Follow up Phase 2: JNJ-73763989 (40 mg) + Placebo + NA n=5 participants at risk Participants who received JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 5: Follow up Phase 2: Placebo + JNJ-56136379 250 mg + NA Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 6: Follow up Phase 2: Placebo + Placebo + NA n=1 participants at risk Participants who received placebo matching to JNJ-73763989 and placebo matching to JNJ-56136379 along with NA up to 48 weeks during double blind phase and who met NA treatment completion criteria at Week 44 and stopped NA at Week 48 were followed-up till Week 96.	Arm 1: Follow up Phase 3: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=3 participants at risk Participants who received JNJ-73763989 100 mg) as SC injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and NA (either ETV monohydrate 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up followed-up till Week 96.	Arm 2: Follow up Period 3: JNJ-73763989 (200mg) + Placebo + NA n=8 participants at risk Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and stopped NA during Follow-up were followed-up till Week 96.	Arm 3: Follow up Phase 3: JNJ-73763989 (100 mg) + Placebo + NA n=5 participants at risk Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 4: Follow up Phase 3: JNJ-73763989 (40 mg) + Placebo + NA Participants who received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up were followed-up till Week 96.	Arm 5: Follow up Phase 3: Placebo + JNJ-56136379 250 mg + NA Participants who received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 6: Follow up Phase 3: Placebo + Placebo + NA Participants who received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase and who met NA treatment completion criteria after Week 44 and Stopped NA during Follow-up followed-up till Week 96.	Arm 1: Extended Follow up: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA n=3 participants at risk Participants received JNJ-73763989 100 mg along with JNJ-56136379 250 mg NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 2: Extended Follow Up: JNJ-73763989 (200 mg) + Placebo + NA n=7 participants at risk Participants received JNJ-73763989 200 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 3: Extended Follow up: JNJ-73763989 (100 mg) + Placebo + NA n=5 participants at risk Participants received JNJ-73763989 100 mg along with placebo matching to JNJ-56136379 NA up to 48 weeks during double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 4: Extended Follow Up: JNJ-73763989 (40 mg) + Placebo + NA Participants received JNJ-73763989 40 mg along with placebo matching to JNJ-56136379 and NA up to 48 weeks in double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 5: Extended Follow Up: Placebo + JNJ-56136379 250 mg + NA Participants received placebo matching to JNJ-73763989 along with a fixed dose of JNJ-56136379 250 mg and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.	Arm 6: Extended Follow Up: Placebo + Placebo + NA Participants received placebo matching to JNJ-73763989 along with placebo matching to JNJ-56136379 and NA up to 48 weeks during the double blind phase. Participants who completed NA treatment during the follow-up phase and completed the assessments of the end of study visit were followed up for extended follow up Week 1 to extended follow up Week 48.
Eye disorders Photopsia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Photophobia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Blood and lymphatic system disorders Anaemia	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 3/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Blood and lymphatic system disorders Leukopenia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Blood and lymphatic system disorders Neutropenia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Cardiac disorders Atrioventricular Block First Degree	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Cardiac disorders Palpitations	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Ear and labyrinth disorders Ear Pain	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Ear and labyrinth disorders Hypoacusis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Ear and labyrinth disorders Otosclerosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Ear and labyrinth disorders Tinnitus	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Ear and labyrinth disorders Vertigo	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.8% 2/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Endocrine disorders Thyroid Cyst	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Blepharospasm	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Chorioretinal Scar	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Conjunctivitis Allergic	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Dry Eye	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Strabismus	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Eye disorders Vision Blurred	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abdominal Distension	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abdominal Pain	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abdominal Pain Upper	3.2% 3/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.9% 2/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Abnormal Faeces	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Chronic Gastritis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Constipation	3.2% 3/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Dental Caries	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Diarrhoea	4.2% 4/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	10.8% 10/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.5% 3/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Dry Mouth	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Dyspepsia	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Dysphagia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Flatulence	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Gastritis	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Gastrointestinal Erosion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Gingival Swelling	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Glossitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Haemorrhoids	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.4% 2/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Haemorrhoids Thrombosed	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Vaccination Site Pain	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Nausea	4.2% 4/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	7.3% 7/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 6/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Tooth Disorder	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Toothache	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.4% 2/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Gastrointestinal disorders Vomiting	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Asthenia	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.2% 5/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	8.3% 4/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	8.9% 4/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.9% 2/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Chest Pain	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Chills	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Fatigue	7.4% 7/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 6/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 3/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.4% 2/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Feeling Hot	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Influenza Like Illness	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.4% 2/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Injection Site Bruising	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Injection Site Erythema	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Injection Site Pain	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Injection Site Reaction	3.2% 3/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Malaise	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Non-Cardiac Chest Pain	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 4/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Oedema Peripheral	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	33.3% 1/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Peripheral Swelling	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Pyrexia	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 3/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.8% 2/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.4% 3/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	28.6% 2/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
General disorders Thirst	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Deficiency of Bile Secretion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Hepatic Cyst	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.8% 2/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	40.0% 2/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Immune system disorders Contrast Media Allergy	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Immune system disorders Hypersensitivity	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Immune system disorders Seasonal Allergy	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Campylobacter Colitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Cellulitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Conjunctivitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Covid-19	4.2% 4/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 4/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.7% 3/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	11.4% 8/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	9.9% 7/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	9.4% 8/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	10.6% 5/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	9.1% 4/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	33.3% 1/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Ear Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Epididymitis	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Eyelid Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Fungal Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Furuncle	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Gastroenteritis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Gastroenteritis Viral	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Genital Herpes	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Helicobacter Infection	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Hordeolum	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Influenza	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Localised Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Nasopharyngitis	6.3% 6/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 4/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	8.6% 8/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.7% 3/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 3/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.5% 3/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Oral Candidiasis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Oral Herpes	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Periodontitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Pharyngitis	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Pulpitis Dental	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Respiratory Tract Infection	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Rhinitis	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Sinusitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Skin Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Tooth Abscess	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Tooth Infection	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Upper Respiratory Tract Infection	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Urinary Tract Infection	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	33.3% 1/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Varicella	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Viral Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Infections and infestations Vulvovaginal Candidiasis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Animal Bite	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Haemoglobin Decreased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Contusion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Head Injury	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Ligament Sprain	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Limb Injury	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Traumatic Tooth Displacement	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Ulna Fracture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Vaccination Complication	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Injury, poisoning and procedural complications Wound	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Alanine Aminotransferase Increased	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Amylase Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Aspartate Aminotransferase Increased	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Beta 2 Microglobulin Increased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Blood Bicarbonate Decreased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Blood Cholesterol Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Blood Creatine Phosphokinase Increased	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Blood Pressure Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Blood Uric Acid Increased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Coagulation Time Prolonged	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Creatinine Renal Clearance Decreased	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Glomerular Filtration Rate Decreased	11.6% 11/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.4% 5/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Lipase Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Serum Ferritin Decreased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Transaminases Increased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Vitamin D Decreased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Investigations Weight Decreased	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 4/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 3/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Back Pain	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.2% 5/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.5% 6/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.6% 4/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.5% 3/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.4% 3/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Joint Range of Motion Decreased	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Muscular Weakness	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Nephrolithiasis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 4/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 4/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.9% 2/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.8% 2/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 1/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	13.3% 2/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Neck Pain	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Pain in Extremity	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Pain in Jaw	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma Benign	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Dizziness	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Dizziness Postural	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Dysgeusia	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Facial Spasm	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Headache	13.7% 13/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	12.5% 12/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	18.3% 17/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	15.1% 14/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	8.3% 4/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	15.6% 7/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.5% 2/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 3/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 3/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.4% 2/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.3% 2/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Hypoaesthesia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Paraesthesia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Sciatica	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.4% 2/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Somnolence	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Nervous system disorders Syncope	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Anxiety	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Confusional State	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Depressed Mood	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Depression	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Insomnia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Psychiatric disorders Sleep Disorder	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Azotaemia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Calculus Urinary	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Dysuria	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Glycosuria	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Leukocyturia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Renal Impairment	3.2% 3/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Renal and urinary disorders Renal Pain	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Atrophic Vulvovaginitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Cervical Dysplasia	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Heavy Menstrual Bleeding	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Menstruation Irregular	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Reproductive system and breast disorders Pruritus Genital	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	14.3% 1/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 6/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.2% 5/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 3/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.9% 2/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Cystic Lung Disease	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	5.9% 1/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.1% 1/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Acne	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Alopecia	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Dry Skin	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 2/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Eczema Asteatotic	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.2% 1/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.0% 1/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Hyperkeratosis Follicularis Et Parafollicularis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Nail Disorder	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Pruritus	2.1% 2/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.2% 3/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	4.2% 2/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.7% 1/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Rash	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 2/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	6.2% 3/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	20.0% 1/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.8% 2/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Social circumstances Menopause	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Vascular disorders Arteriosclerosis	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Vascular disorders Essential Hypertension	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Vascular disorders Hypertension	5.3% 5/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	3.1% 3/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.1% 1/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.2% 1/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	1.4% 1/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.3% 1/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.
Vascular disorders Orthostatic Hypotension	0.00% 0/95 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/96 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/93 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/48 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/45 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/81 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/70 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/71 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/85 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	2.1% 1/47 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/44 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/17 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/15 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/1 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/8 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/3 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/7 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	0.00% 0/5 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.	— 0/0 • Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96; Extended Follow-up Phase: Extended follow up Week 1 to extended follow-up Week 48 Safety analysis set included all participants who received at least one dose of any of the study treatments. At risk = 0 signifies that none of the participant in that arm entered the respective follow up phase.

Additional Information

Study Director

Janssen Sciences Ireland UC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER