Trial Outcomes & Findings for A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (NCT NCT04535544)
NCT ID: NCT04535544
Last Updated: 2025-04-25
Results Overview
Percentage of participants with HDV RNA greater than or equal to (\>=) 2 log10 International Units Per Milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. Target not detected (TND) was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
At Week 48
Results posted on
2025-04-25
Participant Flow
Adult participants co-infected with hepatitis B virus (HBV) and hepatitis D virus (HDV) were considered eligible for participation. Participants with compensated cirrhosis were allowed to be enrolled in Part 1 but excluded from Part 2 of the study.
The study consisted of 2 parts: 1 and 2. Part 2 was initiated when the protocol specified antiviral activity criteria was met in Part 1 and when all participants of Part 1 had completed at least Week 16 or discontinued earlier. Unique participants were randomized (4:1) to JNJ-73763989 + NA and Placebo + NA in Part 1 and 2. Two ongoing participants in double-blind phase Part 2 completed Week 48 visit. Hence, included in the primary analysis at Week 48.
Participant milestones
| Measure |
Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
|---|---|---|---|---|
|
Double-blind (Day 1 up to Week 52)
STARTED
|
17
|
5
|
24
|
6
|
|
Double-blind (Day 1 up to Week 52)
COMPLETED
|
16
|
5
|
20
|
5
|
|
Double-blind (Day 1 up to Week 52)
NOT COMPLETED
|
1
|
0
|
4
|
1
|
|
Open-label (Week 52 up to Week 148)
STARTED
|
5
|
4
|
14
|
5
|
|
Open-label (Week 52 up to Week 148)
COMPLETED
|
5
|
2
|
0
|
0
|
|
Open-label (Week 52 up to Week 148)
NOT COMPLETED
|
0
|
2
|
14
|
5
|
|
Follow-up (Week 148 up to Week 161)
STARTED
|
16
|
3
|
6
|
0
|
|
Follow-up (Week 148 up to Week 161)
COMPLETED
|
7
|
3
|
1
|
0
|
|
Follow-up (Week 148 up to Week 161)
NOT COMPLETED
|
9
|
0
|
5
|
0
|
Reasons for withdrawal
| Measure |
Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
|---|---|---|---|---|
|
Double-blind (Day 1 up to Week 52)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Double-blind (Day 1 up to Week 52)
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
|
Double-blind (Day 1 up to Week 52)
Ongoing after Week 48
|
0
|
0
|
1
|
1
|
|
Open-label (Week 52 up to Week 148)
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Open-label (Week 52 up to Week 148)
Ongoing
|
0
|
1
|
14
|
4
|
|
Follow-up (Week 148 up to Week 161)
Withdrawal by Subject
|
5
|
0
|
4
|
0
|
|
Follow-up (Week 148 up to Week 161)
Ongoing
|
4
|
0
|
0
|
0
|
|
Follow-up (Week 148 up to Week 161)
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Baseline characteristics by cohort
| Measure |
Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Age, Categorical
>=65 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
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 11.96 • n=4 Participants
|
43 years
STANDARD_DEVIATION 10.11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
GERMANY
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
ITALY
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
NEW ZEALAND
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
SPAIN
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
SWEDEN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
TAIWAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
TURKEY
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED STATES
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: Intent-to-Treat analysis set (ITT) included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Percentage of participants with HDV RNA greater than or equal to (\>=) 2 log10 International Units Per Milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. Target not detected (TND) was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
|---|---|---|
|
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
|
23.5 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: ITT analysis set included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
|---|---|---|
|
Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)
|
27.1 Percentage of Participants
|
0.0 Percentage of Participants
|
Adverse Events
DB: Part 1: JNJ-73763989 + NA
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
DB: Part 1: Placebo + NA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DB: Part 2: JNJ-73763989 + NA
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
DB: Part 2: Placebo + NA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OL: Part 1: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
OL: Part 1: Placebo + NA
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
OL: Part 2: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OL: Part 2: Placebo + NA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FU: Part 1: JNJ-73763989 + NA
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
FU: Part 1: Placebo + NA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FU: Part 2: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB: Part 1: JNJ-73763989 + NA
n=17 participants at risk
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 1: Placebo + NA
n=5 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 2: JNJ-73763989 + NA
n=24 participants at risk
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 2: Placebo + NA
n=6 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
OL: Part 1: JNJ-73763989 + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).
|
OL: Part 1: Placebo + NA
n=4 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).
|
OL: Part 2: JNJ-73763989 + NA
n=14 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).
|
OL: Part 2: Placebo + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).
|
FU: Part 1: JNJ-73763989 + NA
n=16 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU: Part 1: Placebo + NA
n=3 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU: Part 2: JNJ-73763989 + NA
n=6 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Eye disorders
Keratitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Transaminases Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Reproductive system and breast disorders
Intermenstrual Bleeding
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
Other adverse events
| Measure |
DB: Part 1: JNJ-73763989 + NA
n=17 participants at risk
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 1: Placebo + NA
n=5 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 2: JNJ-73763989 + NA
n=24 participants at risk
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB: Part 2: Placebo + NA
n=6 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
OL: Part 1: JNJ-73763989 + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).
|
OL: Part 1: Placebo + NA
n=4 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).
|
OL: Part 2: JNJ-73763989 + NA
n=14 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).
|
OL: Part 2: Placebo + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).
|
FU: Part 1: JNJ-73763989 + NA
n=16 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU: Part 1: Placebo + NA
n=3 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU: Part 2: JNJ-73763989 + NA
n=6 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Ear and labyrinth disorders
Motion Sickness
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Eye disorders
Keratitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
7.1%
1/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
17.6%
3/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
2/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Asthenia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
12.5%
3/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Fatigue
|
23.5%
4/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Feeling Hot
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Injection Site Discolouration
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Injection Site Pain
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
General disorders
Vessel Puncture Site Swelling
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hepatic Fibrosis
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hepatomegaly
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Bacteriuria
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Covid-19
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Furuncle
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Helicobacter Infection
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
12.5%
3/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Tooth Abscess
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
50.0%
3/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Limb Crushing Injury
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Alanine Aminotransferase Increased
|
52.9%
9/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
29.2%
7/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
50.0%
2/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
18.8%
3/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
66.7%
4/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Amylase Increased
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Aspartate Aminotransferase Increased
|
41.2%
7/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
4/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
18.8%
3/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
2/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Beta 2 Microglobulin Increased
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Bilirubin Conjugated Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Blood Bilirubin Increased
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
7.1%
1/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Human Chorionic Gonadotropin Positive
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Transaminases Increased
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
12.5%
2/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Investigations
Weight Decreased
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Metabolism and nutrition disorders
Gout
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
7.1%
1/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
20.0%
1/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Liver
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Burning Sensation
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
7.1%
1/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
7.1%
1/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Intercostal Neuralgia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Lethargy
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
25.0%
1/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
12.5%
2/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Renal and urinary disorders
Polyuria
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
33.3%
1/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Alopecia Areata
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
8.3%
2/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
5.9%
1/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Skin and subcutaneous tissue disorders
Umbilical Erythema
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
6.2%
1/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
4.2%
1/24 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
16.7%
1/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/4 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/14 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/5 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/16 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/3 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
0.00%
0/6 • From Day 1 to Week 52 in double-blind (DB) phase, from Week 52 to Week 148 in open-label (OL) phase and from Week 148 to Week 161 in follow-up (FU) phase
Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Adverse event data collection is still ongoing and will be updated upon study completion. As none of the participants entered the follow-up phase from open-label phase 'Part 2: Placebo + NA' arm, hence, no data was collected and this arm is not reported in adverse event section.
|
Additional Information
Senior Director Medical Lead
Janssen Research & Development, LLC
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 withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER