Trial Outcomes & Findings for Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy (NCT NCT05513937)

Last Updated: 2025-02-04

Results Overview

To assess the antihypertensive efficacy of the extemporaneous combination of Nebivolol (NEB) 5 mg in combination with Amlodipine (AML) 5 mg or AML 10 mg in lowering the sitting diastolic BP between Visit 2 (Week 0) and Visit 4 (Week 8) in patients with uncontrolled BP previously treated with Nebivolol or Amlodipine (5 mg) monotherapies for at least 4 weeks during run-in period.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

301 participants

Primary outcome timeframe

From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks

Results posted on

2025-02-04

Participant Flow

MONOTHERAPY PERIOD:Patients are treated with NEB 5 mg or AML 5 mg during the Run in period (week -4 to week 0) according the assigned arms. Uncontrolled patients enter the COMBINATION THERAPY PERIOD, a one arm assessment period of 8 weeks (week 0 to week 8), where patient are treated with extemporaneous combination of NEB 5 mg/AML 5mg for 4 weeks. AML 10mg will replace AML 5mg in uncontrolled patients for further 4 weeks while controlled patients will continue with the same combination therapy.

Participant milestones

Participant milestones
Measure	Run-In Nebivolol 5mg MONOTHERAPY PHASE (Run-in 4 weeks from -4 week to week 0): patients will be treated with Nebivolol 5mg Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator.	Run-In Amlodipine 5mg MONOTHERAPY PHASE (Run-in 4 weeks from -4 week to week 0): patients will be treated with Amlodipine 5mg. Amlodipine: Tablets of 5mg administered orally once daily according instructions provided by Principal Investigator.	Combination Therapy Nebivolol 5mg/ Amlodipine 5mg COMBINATION THERAPY PHASE (8 weeks from week 0 to week 8): uncontrolled patients taking Nebivolol 5 mg or Amlodipine 5mg during the respective Run-in Phases, will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4).Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 5mg administered orally once daily according instructions provided by Principal Investigator.	Combination Therapy Nebivolol 5mg/ Amlodipine 10mg COMBINATION THERAPY PHASE (4 weeks from week 4 to week 8): Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4), for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 10mg administered orally once daily according instructions provided by Principal Investigator.
Run in (-4 Week to 0) Monotherapy Phase STARTED	143	158	0	0
Run in (-4 Week to 0) Monotherapy Phase COMPLETED	139	152	0	0
Run in (-4 Week to 0) Monotherapy Phase NOT COMPLETED	4	6	0	0
Combination Therapy (0 to 4 Weeks) STARTED	0	0	279	0
Combination Therapy (0 to 4 Weeks) COMPLETED	0	0	279	0
Combination Therapy (0 to 4 Weeks) NOT COMPLETED	0	0	0	0
Combination Therapy (4 to 8 Weeks) STARTED	0	0	185	94
Combination Therapy (4 to 8 Weeks) COMPLETED	0	0	182	94
Combination Therapy (4 to 8 Weeks) NOT COMPLETED	0	0	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-In Nebivolol 5mg MONOTHERAPY PHASE (Run-in 4 weeks from -4 week to week 0): patients will be treated with Nebivolol 5mg Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator.	Run-In Amlodipine 5mg MONOTHERAPY PHASE (Run-in 4 weeks from -4 week to week 0): patients will be treated with Amlodipine 5mg. Amlodipine: Tablets of 5mg administered orally once daily according instructions provided by Principal Investigator.	Combination Therapy Nebivolol 5mg/ Amlodipine 5mg COMBINATION THERAPY PHASE (8 weeks from week 0 to week 8): uncontrolled patients taking Nebivolol 5 mg or Amlodipine 5mg during the respective Run-in Phases, will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4).Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 5mg administered orally once daily according instructions provided by Principal Investigator.
Run in (-4 Week to 0) Monotherapy Phase Newly developed or not previously recognized exclusion criteria	0	1	0
Run in (-4 Week to 0) Monotherapy Phase Protocol Violation	2	5	0
Run in (-4 Week to 0) Monotherapy Phase Physician Decision	1	0	0
Run in (-4 Week to 0) Monotherapy Phase Withdrawal by Subject	1	0	0
Combination Therapy (4 to 8 Weeks) Adverse Event	0	0	2
Combination Therapy (4 to 8 Weeks) Protocol Violation	0	0	1

Baseline Characteristics

Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy Nebivolol 5mg/ Amlodipine 5mg n=185 Participants COMBINATION THERAPY PHASE (8 weeks from week 0 to week 8): uncontrolled patients taking Nebivolol 5 mg or Amlodipine 5mg during the respective Run-in Phases, will be treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from week 0 to week 4). Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks (from week 4 to week 8) while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 5mg administered orally once daily according instructions provided by Principal Investigator.	Combination Therapy Nebivolol 5mg/ Amlodipine 10mg n=94 Participants COMBINATION THERAPY PERIOD: (4 weeks from Week 4 to Week 8): Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients treated with the extemporaneous combination of Nebivolol 5mg and Amlodipine 5mg for 4 weeks (from Week 0 to Week 4), for further 4 weeks, while controlled patients with Nebivolol 5mg/Amlodipine 5mg, will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.	Total n=279 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 8.14 • n=99 Participants	53.4 years STANDARD_DEVIATION 8.02 • n=107 Participants	52.2 years STANDARD_DEVIATION 8.13 • n=206 Participants
Sex: Female, Male Female	99 Participants n=99 Participants	45 Participants n=107 Participants	144 Participants n=206 Participants
Sex: Female, Male Male	86 Participants n=99 Participants	49 Participants n=107 Participants	135 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=99 Participants	94 Participants n=107 Participants	279 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: From Visit 2 (week 0) to Visit 4 (week 8) for a total of 8 weeks

Population: Primary endpoint (as per protocol assessed in patients who received combination therapy regardless of AML dose), is defined as mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)

Outcome measures

Outcome measures
Measure	Combination Therapy Phase Nebivolol 5mg/Amlodipine 5 or 10 mg n=276 Participants Combination Therapy Phase (8 weeks) from Visit 2 (week 0) to Visit 4 (week 8): uncontrolled patients with Monotherapy (Nebivolol 5 mg or Amlodipine 5 mg) are treated with the extemporaneous combination of Nebivolol 5 mg and Amlodipine 5mg for 4 weeks. Amlodipine 10mg will replace Amlodipine 5mg in uncontrolled patients for further 4 weeks while controlled patients with Nebivolol 5mg/Amlodipine 5mg will continue with the same therapy. Nebivolol: Tablets administered orally once daily according instructions provided by Principal Investigator. Amlodipine: Tablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.
Change in Mean Sitting Diastolic Blood Pressure (DBP) Between Visit 2 (Week 0) and Visit 4 (Week 8)	-15.2 mmHg Standard Deviation 8.32

Adverse Events

Nebivolo 5 mg MONOTHERAPY PERIOD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Amlodipine 5 mg MONOTHERAPY PERIOD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operation Director

A. Menarini Industrie Farmaceutiche Riunite SrL

Phone: 055 5680459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	Nebivolo 5 mg MONOTHERAPY PERIOD n=143 participants at risk All patients Enrolled who received at least one dose of Nebivolol 5mg in Monotherapy during the Run in Phase ( from -4 week to week 0)	Amlodipine 5 mg MONOTHERAPY PERIOD n=158 participants at risk All patients Enrolled who received at least one dose of Amlodipine 5mg in Monotherapy during the Run in Phase ( from -4 week to week 0)	Nebivolo 5mg/Amlodipine 5 mg COMBINATION THERAPY PERIOD n=279 participants at risk All patients Enrolled who received at least one dose of the Combination therapy: Nebivolol 5mg/Amlodipine 5 from week 0 to week 8	Nebivolo 5mg/Amlodipine 10mg COMBINATION THERAPY PERIOD n=94 participants at risk All patients Enrolled who received at least one dose of the Combination therapy: Nebivolol 5mg/Amlodipine 10mg from week 0 to week 8
Vascular disorders Flushing	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
General disorders Feeling Hot	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Reproductive system and breast disorders Endometrial hyperplasia	0.70% 1/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Reproductive system and breast disorders Ovarian cyst	0.70% 1/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Gamma-glutamyltransferase increased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.72% 2/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Blood creatinine increased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Blood uric acid increased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Glomerular filtration rate decreased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Heart rate increased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations SARS-CoV-2 test positive	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Investigations Hepatic enzyme increased	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	3.2% 3/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Cardiac disorders Palpitations	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Cardiac disorders Tachycardia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Nervous system disorders Headache	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	2.5% 7/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Nervous system disorders Intracranial aneurysm	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Ear and labyrinth disorders Vertigo	0.70% 1/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 3/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Gastrointestinal disorders Toothache	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 3/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Gastrointestinal disorders Diarrhoea	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.72% 2/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Skin and subcutaneous tissue disorders Hyperhidrosis	0.70% 1/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Skin and subcutaneous tissue disorders Peripheral swelling	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Skin and subcutaneous tissue disorders Erythema	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Endocrine disorders Thyroid disorder	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.63% 1/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	2.2% 6/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 3/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	3.2% 3/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Infections and infestations COVID-19	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Infections and infestations Nasopharyngitis	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Infections and infestations Respiratory tract infection	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Hyperglycaemia	0.70% 1/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Upper respiratory tract infection	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Dehydration	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.36% 1/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/143 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/158 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	0.00% 0/279 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term	1.1% 1/94 • From Informed Consent signature at screening visit (Visit 1) occurring 4 week previous than Baseline assessment (Week 0 - Visit 2) to last visit at Week 8 (Visit 4) for an average of 12 weeks. Furthermore patients having any ongoing Adverse Event/Serious Adverse Event at the end of the treatment (Week 8 - Visit 4), will be followed for further 2 weeks via a phone call to check about the status of the Adverse Events/Serious Adverse Events, extending the time frame to a total of 14 weeks. Safety analyses were carried out using the Safety analysis population, which was defined as all patients in the Enrolled population who received at least one dose of study medication (i.e., monotherapy and/or combination therapy ) If a patient reports the same Adverse Event (AE) more than once within that System Organ Class/Preferred Term, then that patient will be counted only once for that System Organ Class or Preferred Term