Trial Outcomes & Findings for Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT01185821)

Last Updated: 2018-03-27

Results Overview

Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

185 participants

Primary outcome timeframe

Baseline up to approximately 5 years

Results posted on

2018-03-27

Participant Flow

All patients enrolled in the Extension study had completed the Core study. All patients underwent a 10 day titration at the start of the dose blinded phase of the study

During the double blind phase of the extension study patients received the same dose from the Core study. Placebo patients from Core Period 1 were randomized to 0.5, 2 or 10mg, those from Period 2 were randomized to 0.25 or 1.25 mg. All patients received 2mg in Open Label phase (.5 and .25mg were titrated up to 2mg)

Participant milestones

Participant milestones
Measure	BAF312 10 mg/2 mg 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Overall Study STARTED	33	29	43	29	50
Overall Study Patients With Washout	33	29	39	29	33
Overall Study Patients Without Washout	0	0	4	0	17
Overall Study Patients on Placebo in Core	8	7	9	8	2
Overall Study COMPLETED	26	20	33	23	26
Overall Study NOT COMPLETED	7	9	10	6	24

Reasons for withdrawal

Reasons for withdrawal
Measure	BAF312 10 mg/2 mg 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Overall Study Abnormal laboratory value(s)	1	2	1	0	0
Overall Study Protocol Violation	0	0	0	1	1
Overall Study Abnormal test procedure result	0	0	0	0	1
Overall Study Death	0	1	0	0	0
Overall Study Condition no longer required study drug	0	0	0	0	1
Overall Study Adverse Event	2	3	1	2	5
Overall Study Lack of Efficacy	0	0	3	0	9
Overall Study Withdrawal by Subject	3	2	2	1	3
Overall Study Lost to Follow-up	1	1	2	1	2
Overall Study Administrative problems	0	0	1	1	2

Baseline Characteristics

Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	Total n=184 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 9.09 • n=99 Participants	35.1 years STANDARD_DEVIATION 9.16 • n=107 Participants	34.0 years STANDARD_DEVIATION 7.57 • n=206 Participants	35.2 years STANDARD_DEVIATION 9.10 • n=157 Participants	37.2 years STANDARD_DEVIATION 8.42 • n=390 Participants	35.7 years STANDARD_DEVIATION 8.59 • n=16 Participants
Sex: Female, Male Female	21 Participants n=99 Participants	18 Participants n=107 Participants	32 Participants n=206 Participants	18 Participants n=157 Participants	41 Participants n=390 Participants	130 Participants n=16 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	11 Participants n=107 Participants	11 Participants n=206 Participants	11 Participants n=157 Participants	9 Participants n=390 Participants	54 Participants n=16 Participants
Expanded disability status scale (EDSS)	2.03 units on a scale STANDARD_DEVIATION 0.960 • n=99 Participants	2.19 units on a scale STANDARD_DEVIATION 1.278 • n=107 Participants	1.95 units on a scale STANDARD_DEVIATION 1.096 • n=206 Participants	1.88 units on a scale STANDARD_DEVIATION 1.374 • n=157 Participants	2.22 units on a scale STANDARD_DEVIATION 1.258 • n=390 Participants	2.07 units on a scale STANDARD_DEVIATION 1.190 • n=16 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 5 years

Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. Serious adverse events	4 events	7 events	6 events	6 events	8 events
Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. Other adverse events	30 events	26 events	42 events	29 events	42 events

PRIMARY outcome

Timeframe: Baseline Extension up to day 10

Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for \>7 days. Abbreviation: Con=conduction, IVCD=intraventricular conduction defect , WPW=Wolff-Parkinson-White syndrome

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=39 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=33 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) Conduction-Prolonged QTc	5 participants	2 participants	5 participants	2 participants	4 participants
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) Conduction - IVCD	3 participants	8 participants	1 participants	3 participants	0 participants
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) Conduction - AV Mobitz I	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) Con:1st degree AV block	0 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) Conduction - WPW	0 participants	0 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Baseline Extension up to day 10

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=4 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)	4 participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline Extension up to approximately 5 years

Sitting blood pressure was measured in triplicate. The categories of notably low and high values and changes are presented for systolic (SBP) and diastolic (DBP). Multiple occurrences for a patient are counted as one occurrence in this table.

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) SBP Low: ≤ 90	1 participants	3 participants	2 participants	1 participants	1 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) SBP ≥ 20 decrease from baseline	8 participants	10 participants	4 participants	6 participants	10 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) SBP High: ≥ 160	1 participants	1 participants	1 participants	3 participants	3 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) SBP ≥ 20 increase from baseline	9 participants	8 participants	12 participants	13 participants	18 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) DBP Low: ≤ 50	1 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) DBP ≥ 15 decrease from baseline	14 participants	8 participants	10 participants	10 participants	10 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) DBP High: ≥ 100	4 participants	7 participants	4 participants	4 participants	4 participants
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) DBP ≥ 15 increase from baseline	9 participants	13 participants	13 participants	11 participants	17 participants

PRIMARY outcome

Timeframe: Baseline Extension up to approximately 5 years

Most infections were clinical diagnoses and were not confirmed by microbiology / virologic investigations. A patient with multiple occurrences of an infection for a preferred term is counted only once in each specific category. Events identified as infections by the Investigator and defined as an AE with onset on or after the first dose of Extension Study drug up to and including 30 days after the date of the last dose

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) Oral herpes	5 participants	0 participants	4 participants	2 participants	4 participants
Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) Herpes zoster	5 participants	0 participants	3 participants	2 participants	0 participants
Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) Influenza	3 participants	4 participants	3 participants	6 participants	6 participants

PRIMARY outcome

Timeframe: Baseline Extension up to approximately 5 years

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)	1 participants	0 participants	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline extension up to approximately 5 years

Group level ARR (raw) is calculated as the total number of relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate. Model estimates are based on a negative binomial regression model, adjusted for treatment group, age, baseline EDSS, baseline number of Gd-enhanced T1 lesions and number of relapses in previous 2 years as covariates, with log(time on study in years) as the offset variable, using the log link.

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)	0.18 Group level ARR Interval 0.11 to 0.31	0.15 Group level ARR Interval 0.08 to 0.26	0.16 Group level ARR Interval 0.1 to 0.26	0.19 Group level ARR Interval 0.11 to 0.33	0.22 Group level ARR Interval 0.14 to 0.35

SECONDARY outcome

Timeframe: Baseline Extension up to approximately 5 years

Free of MRI disease activity is defined as free of Gadolinium enhanced T1 lesions at any scan; free of new or enlarging T2 lesions at any scan: free of both gadolinium enhanced T1 lesions and new or enlarging T2 lesions at any scan. Number of patients analyzed = patients with at least one MRI scan during the specified time period. New lesions at a specific visit are assessed relative to the previous scheduled visit scan. No imputation of missing scans is performed. As a result missing scans can lead to an overestimation of the proportion of patients free of a specific MRI activity.

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=31 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=26 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=47 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set) Free of Gd-enhanced T1 lesions at any scan	58.1 percentage of participants	57.7 percentage of participants	58.1 percentage of participants	44.8 percentage of participants	66.0 percentage of participants
Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set) Free of new/enlarging T2 lesions at any scan	32.3 percentage of participants	42.3 percentage of participants	46.5 percentage of participants	20.7 percentage of participants	40.4 percentage of participants
Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set) Free of Gd-enhanced T1 and new enlarged T2 lesions	32.3 percentage of participants	42.3 percentage of participants	44.2 percentage of participants	20.7 percentage of participants	40.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline Extension up to approximately 5 years

Six-month disability progression was defined relative to extension baseline EDSS score: 1.5 point increase in patients with baseline EDSS score of 0, 1.0 increase in patients with baseline EDSS score of between 0.5 to 5.0, inclusive and 0.5 increase in patients with baseline EDSS score of ≥ 5.5. The criteria for 6-month disability progression included detection of onset of progression and confirmation of progression for a period of at least 6 months.

Outcome measures

Outcome measures
Measure	BAF312 10 mg/2 mg n=33 Participants 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 2 mg/2 mg n=29 Participants 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 1.25 mg/2 mg n=43 Participants 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .5 mg/2 mg n=29 Participants .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase	BAF312 .25 mg/2 mg n=50 Participants .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)	72.3 percentage of participants Interval 56.0 to 88.7	82.4 percentage of participants Interval 66.6 to 98.3	84.8 percentage of participants Interval 73.5 to 96.0	81.4 percentage of participants Interval 66.6 to 96.1	78.6 percentage of participants Interval 65.4 to 91.9

Adverse Events

BAF312 10/2 mg

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

BAF312 2/2 mg

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

BAF312 1.25/2 mg

Serious events: 6 serious events

Other events: 42 other events

Deaths: 0 deaths

BAF312 0.5/2 mg

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

BAF312 0.25/2 mg

Serious events: 8 serious events

Other events: 42 other events

Deaths: 0 deaths

All Patients

Serious events: 31 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BAF312 10/2 mg n=33 participants at risk BAF312 10/2 mg	BAF312 2/2 mg n=29 participants at risk BAF312 2/2 mg	BAF312 1.25/2 mg n=43 participants at risk BAF312 1.25/2 mg	BAF312 0.5/2 mg n=29 participants at risk BAF312 0.5/2 mg	BAF312 0.25/2 mg n=50 participants at risk BAF312 0.25/2 mg	All Patients n=184 participants at risk All patients
Blood and lymphatic system disorders Splenic cyst	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Ear and labyrinth disorders Otosclerosis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Glaucoma	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Gastritis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Nausea	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Vomiting	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Submandibular mass	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Immune system disorders Anaphylactic reaction	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Oral herpes	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Pyelonephritis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Pyelonephritis acute	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Respiratory tract infection	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Upper respiratory tract infection	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Urinary tract infection	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Smear cervix abnormal	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Dysaesthesia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Headache	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Sciatica	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Seizure	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Depression	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Drug abuse	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Mental disorder	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Reproductive system and breast disorders Metrorrhagia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Reproductive system and breast disorders Uterine cervical metaplasia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.54% 1/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Other adverse events

Other adverse events
Measure	BAF312 10/2 mg n=33 participants at risk BAF312 10/2 mg	BAF312 2/2 mg n=29 participants at risk BAF312 2/2 mg	BAF312 1.25/2 mg n=43 participants at risk BAF312 1.25/2 mg	BAF312 0.5/2 mg n=29 participants at risk BAF312 0.5/2 mg	BAF312 0.25/2 mg n=50 participants at risk BAF312 0.25/2 mg	All Patients n=184 participants at risk All patients
Psychiatric disorders Sleep disorder	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Sinusitis	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	17.2% 5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.0% 5/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.8% 18/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.0% 5/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.5% 12/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Blood and lymphatic system disorders Leukopenia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Blood and lymphatic system disorders Lymphopenia	18.2% 6/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	17.2% 5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	20.7% 6/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.0% 24/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Cardiac disorders Palpitations	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Cardiac disorders Tachycardia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Ear and labyrinth disorders Ear pain	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Ear and labyrinth disorders Tinnitus	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Ear and labyrinth disorders Vertigo	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	12.0% 6/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.7% 16/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Ear and labyrinth disorders Vertigo positional	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Conjunctivitis	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Eye pain	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Iridocyclitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Vision blurred	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Abdominal pain	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	17.2% 5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.5% 12/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Constipation	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Diarrhoea	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.3% 7/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	12.0% 6/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 19/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Dyspepsia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Enteritis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Gastritis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Nausea	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.3% 8/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Toothache	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 11/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Gastrointestinal disorders Vomiting	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Asthenia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Fatigue	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	11.6% 5/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	12.0% 6/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.8% 18/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Gait disturbance	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Influenza like illness	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Non-cardiac chest pain	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Oedema peripheral	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
General disorders Pyrexia	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.0% 5/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.2% 15/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Acute sinusitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Bronchitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	11.6% 5/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	12.0% 6/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.7% 16/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Conjunctivitis	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Cystitis	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.3% 8/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Fungal infection	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Fungal skin infection	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Gastroenteritis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	5.4% 10/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Gastroenteritis viral	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Herpes zoster	15.2% 5/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	5.4% 10/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Influenza	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	11.6% 5/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	24.1% 7/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.0% 7/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.7% 27/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Nasopharyngitis	30.3% 10/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	27.6% 8/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	39.5% 17/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	37.9% 11/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	36.0% 18/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	34.8% 64/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Onychomycosis	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Oral herpes	15.2% 5/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.2% 15/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Otitis media	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Pharyngitis	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	20.7% 6/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.2% 17/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Pneumonia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Respiratory tract infection	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Rhinitis	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Subcutaneous abscess	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Tinea versicolour	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Tonsillitis	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	11.6% 5/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	5.4% 10/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Tooth infection	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Upper respiratory tract infection	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	20.7% 6/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	24.1% 7/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	18.0% 9/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.3% 30/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Urinary tract infection	18.2% 6/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.9% 20/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Vaginal infection	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Contusion	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.3% 8/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Fall	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.9% 9/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Joint injury	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Ligament sprain	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Limb injury	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Alanine aminotransferase increased	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	17.2% 5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.2% 15/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Blood bilirubin increased	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Blood cholesterol increased	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations C-reactive protein increased	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Gamma-glutamyltransferase increased	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.1% 13/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Hepatic enzyme increased	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Investigations Lymphocyte count decreased	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.2% 15/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Metabolism and nutrition disorders Hypercholesterolaemia	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.5% 12/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.6% 14/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Back pain	18.2% 6/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	11.6% 5/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 19/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Joint swelling	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Muscle spasms	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Muscular weakness	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.9% 9/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Musculoskeletal and connective tissue disorders Neck pain	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.0% 6/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.0% 7/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.8% 18/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	5.4% 10/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Burning sensation	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Dizziness	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.3% 8/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Headache	27.3% 9/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	20.9% 9/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	20.0% 10/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	19.6% 36/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Hypoaesthesia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Migraine	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.3% 6/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Muscle spasticity	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Neuralgia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.3% 4/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Paraesthesia	12.1% 4/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.9% 9/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Anxiety	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.0% 4/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.9% 9/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Depression	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.0% 6/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	14.0% 7/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	9.8% 18/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Psychiatric disorders Insomnia	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	18.6% 8/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	12.0% 6/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.9% 20/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Renal and urinary disorders Bladder dysfunction	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Renal and urinary disorders Micturition urgency	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Renal and urinary disorders Nephrolithiasis	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Renal and urinary disorders Urinary retention	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Catarrh	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	13.8% 4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.2% 15/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	5.4% 10/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Alopecia	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Dermal cyst	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.0% 2/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.2% 4/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Dermatitis contact	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.6% 3/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Eczema	9.1% 3/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.3% 8/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Hyperkeratosis	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	1.1% 2/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Pigmentation disorder	6.1% 2/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.9% 2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.3% 1/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Pruritus	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	4.7% 2/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	6.0% 3/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.8% 7/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.0% 1/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	2.7% 5/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Vascular disorders Hypertension	3.0% 1/33 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	3.4% 1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	7.0% 3/43 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	10.3% 3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.0% 8/50 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	8.7% 16/184 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER